Corporate Events

Eisai Co., Ltd. and Biogen Inc. announced that "LEQEMBI Pen", the subcutaneous (SC) formulation of the anti-amyloid beta (A) protofibril antibody "LEQEMBI" (brand name, generic name: lecanemab) has been approved in Japan as a new route of administration. LEQEMBI Pen is an autoinjector formulation that enables administration by a care partner or patient self-administration, with two pens (totaling 500 mg) administered once weekly. With this approval, LEQEMBI treatment now offers a new option of once-weekly SC administration at home, in addition to intravenous (IV) administration every two weeks in a hospital setting. LEQEMBI Pen may reduce the time required for anti-amyloid therapy administration compared with IV infusions (approximate injection time of 15 seconds per injection). In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and provide greater flexibility in treatment, allowing patients to make treatment choices that better fit their lifestyles, including fewer constraints on going out and traveling. LEQEMBI Pen also has the potential to reduce healthcare resources associated with IV dosing, such as nurse monitoring, as well as maintaining infusion capacity. For amyloid-related imaging abnormalities (ARIA) monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation. Only LEQEMBI fights AD in two ways - targeting both protofibrils and amyloid plaque. This marks the third country globally to approve LEQEMBI SC formulation. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple SC administration sub-studies in its subsequent long-term extension study (LTE). Once-weekly administration of SC formulation 500 mg demonstrated similar exposure to IV administration once every two weeks and supported the expectation that the SC formulation provides efficacy comparable to that of the IV formulation. The overall safety profile of SC administration was generally similar to that of IV administration, while systemic injection/infusion-related reactions were observed less frequently with SC administration (1.4%) than with IV administration. When initiating administration, treatment must be administered by a physician or under the direct supervision of a physician at a medical facility. With regard to the applicability of self-administration, the appropriateness thereof shall be carefully considered, and only after providing thorough education and training, and confirming that the patient or family member/caregiver understands the risks associated with administration of this drug and how to respond to them, and that the patient or family member/caregiver is able to reliably administer it themselves, shall self-administration be implemented under the management and guidance of a physician. LEQEMBI Pen Product Outline: Product name: LEQEMBI Pen; Generic name: Lecanemab (recombinant); Indication for use: Slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease; Dosage and administration: The usual dose of lecanemab (recombinant) is 500 mg injected subcutaneously once weekly. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (A). Lecanemab has been approved in 53 countries and regions including Japan, the U.S., China, Canada, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. In September 2023, Eisai received approval in Japan for lecanemab as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 9 countries and regions including the U.S., China, the UK, and others, and applications have been filed in 11 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing (360 mg) with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the U.S. in July 2026 and China in September 2026, and applications are under review in 2 countries. Protofibrils are thought to be the most toxic A species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms. The mechanism by which this occurs has been reported not only by increasing the formation of insoluble A plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.

BioArctic AB's partner Eisai announced that the subcutaneous autoinjector formulation of Leqembi (known as Leqembi Pen in Japan) has been approved as a new route of administration for the treatment of early Alzheimer's disease. Leqembi Pen enables patients or care partners to self-administer treatment, with two injections (totaling 500 mg) given once weekly. This approval in Japan provides people living with early Alzheimer's disease with an additional treatment option, allowing once-weekly subcutaneous administration at home, complementing the existing intravenous (IV) formulation, which is administered every two weeks in a hospital setting. Leqembi Pen may reduce the time required for treatment administration compared with IV infusions, with each injection taking approximately 15 seconds. The option for at-home administration may reduce the burden of clinic visits for patients and their care partners and provide a treatment option that better fits their lifestyles. The subcutaneous treatment option is expected to lower barriers to initiating and continuing treatment and has the potential to reduce healthcare resources associated with IV administration, such as nurse monitoring and maintaining infusion capacity. As with IV administration, monitoring for ARIA (amyloid-related imaging abnormalities) involves brain magnetic resonance imaging (MRI) before treatment is initiated and at specified time points thereafter. Japan is the third country globally to approve the subcutaneous formulation of Leqembi. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of Leqembi in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple subcutaneous administration sub-studies in its subsequent long-term extension (LTE). Once-weekly administration of the 500 mg subcutaneous formulation demonstrated similar exposure to IV administration once every two weeks and supported the expectation that the subcutaneous formulation provides efficacy comparable to that of the IV formulation. The overall safety profile of subcutaneous administration was generally similar to that of IV administration, while systemic injection/infusion-related reactions were observed less frequently with subcutaneous administration (1.4%) compared with IV administration. Leqembi is approved in 53 countries and is under regulatory review in 6 countries and regions. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in nine countries and regions, including the US, Japan, China and the United Kingdom, and applications have been filed in eleven countries and regions. In the US, Leqembi Iqlik is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. Subcutaneous initiation treatment was approved in China in September 2026, and applications are under review in two countries. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß).

Eisai Co., Ltd. and Biogen Inc. announced that the National Medical Products Administration (NMPA) of China has approved the subcutaneous formulation (subcutaneous autoinjector: SC-AI), the anti-amyloid beta (Aß) protofibril antibody LEQEMBI (generic name: lecanemab) as an initiation treatment for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia (collectively referred to as early AD). The application was accepted by the NMPA in January 2026 and was subsequently granted Priority Review designation. Launch is planned during Eisai's Fiscal Year 2026, ending March 31, 2027. LEQEMBI SC-AI is a self-administered autoinjector formulation. The approved regimen is 500 mg given once weekly as two consecutive 250 mg injections. With this approval, LEQEMBI treatment now offers a new option of once-weekly SC administration at home, in addition to intravenous (IV) administration every two weeks in a hospital setting. Patients may also switch from IV to SC administration, or vice versa, during treatment. LEQEMBI SC-AI may significantly reduce the time required compared with IV infusions (approximate injection time of 15 seconds per injection). In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and enable treatment options that better fit their lifestyles, providing greater flexibility for going out and traveling. The improved convenience and flexibility of treatment with LEQEMBI is expected to lower barriers to initiating and continuing treatment with LEQEMBI. Furthermore, LEQEMBI SC-AI also has the potential to reduce healthcare resources associated with IV dosing, such as nurse monitoring, as well as maintaining infusion capacity. These features are expected to contribute to further streamlining the overall AD treatment pathway. For ARIA (amyloid-related imaging abnormalities) monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation. AD is a relentless disease with Aß and tau as hallmarks, caused by a continuous underlying neurotoxic process driven by protofibrils that begins before amyloid plaque accumulation and continues after plaque removal. Only LEQEMBI fights AD in two ways – targeting both protofibrils and amyloid plaque. This marks the second country globally to approve LEQEMBI SC-AI. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with early AD, as well as multiple subcutaneous (SC) administration sub-studies (including the Chinese cohort) in its subsequent long-term extension (LTE). Once-weekly administration of SC-AI 500mg demonstrated exposure equivalent to once every two weeks IV administration, with similar clinical and biomarker benefits. The overall safety profile of SC administration was generally similar to that of IV administration. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed. Eisai estimates that there were 17 million patients with MCI or mild dementia due to AD in China in 2024, which is expected to increase as the population ages. LEQEMBI was launched in China in June 2024 and is leading the establishment of anti-amyloid therapy in AD management, expanding its contribution to patients with early AD. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the U.S., China, Canada, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 9 countries and regions including the U.S., China, the UK, and others, and applications have been filed in 11 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the United States in July 2026, and applications are under review in three countries, including Japan. LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's global placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Clarity AD evaluated lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897). 95% of patients who completed the core study (18 months) chose to continue in the long-term extension study (LTE), with 478 patients still receiving treatment for four years. In the Clarity AD core clinical study, data showed LEQEMBI IV significantly slowed disease progression at 18 months (27% vs placebo), and the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.

Eisai Co., Ltd. and Biogen Inc. announced that Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of LEQEMBI (lecanemab) for eligible patients in Canada living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (early AD). The final recommendation follows a reconsideration by CDA-AMC and is an important step toward access to LEQEMBI. Next steps include negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA), followed by individual reimbursement decisions by public drug plans in Canada's provinces and territories. More than 770,000 people in Canada were estimated to be living with dementia in 2025, and the number of people living with dementia in Canada is projected to increase to 1,700,000 by 2050. Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (A). Lecanemab has been approved in 53 countries and regions including Japan, the U.S., China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the United States in July 2026, and applications are under review in four countries, including Japan and China. In China, the application has been granted Priority Review designation. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List," recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. Protofibrils are thought to be the most toxic A species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms. The mechanism by which this occurs has been reported not only by increasing the formation of insoluble A plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

BioArctic's partner Eisai announced that Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for eligible patients in Canada with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (early AD). The final recommendation follows a reconsideration by CDA-AMC and represents an important step toward broadening access to Leqembi in Canada. Next steps include negotiations through the pan-Canadian Pharmaceutical Alliance, followed by reimbursement decisions by public drug plans across Canada's provinces and territories. More than 770,000 people in Canada were estimated to be living with dementia in 2025, and that number is projected to increase to 1,700,000 by 2050. Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Leqembi is approved in 53 countries and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries, including the United Kingdom, China, the US and Japan, and applications have been filed in 12 countries and regions. In the US, Leqembi Iqlik is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi for initiation treatment was submitted in Japan. In December 2025, Leqembi was included in the Commercial Insurance Innovative Drug List, recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd. and Biogen Inc. announced that once weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK) is now available in the U.S. for initiation therapy for early Alzheimer's disease (AD) in adults with mild cognitive impairment (MCI) or mild dementia due to AD, collectively referred to as early AD. LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two consecutive 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous (SC) treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as SC injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration. The availability of LEQEMBI IQLIK for both initiation and maintenance therapy in the U.S. enhances treatment convenience and flexibility, offering early AD patients and their care partners more control in managing their care while lowering barriers to initiating and continuing treatment with LEQEMBI. LEQEMBI IQLIK may reduce the time spent receiving anti-amyloid therapy via IV infusions. In addition, at-home administration allows patients and their care partners to continue treatment without the burden of clinic visits, making it easier to go out and travel. LEQEMBI IQLIK also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring. For ARIA monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation. Eisai and Biogen will provide a range of resources to help patients, care partners, healthcare providers, health systems and pharmacies successfully implement and use LEQEMBI IQLIK. Resources include an Instructions for Use (IFU) video and IQLIK Welcome Kit. The IQLIK Welcome Kit provides a What to Expect Treatment Tracker, an injection reminder magnet, and a Demo Kit to help patients and care partners understand what to expect, prepare for at-home injections, and administer injections safely at home. The LEQEMBI Companion app will also be available. It brings the information patients and care partners need into one experience, including education about the injection process and tools for tracking each dose. Through the LEQEMBI Specialty Pharmacy Network, patients may receive support with prescription fulfillment, insurance coverage navigation, onboarding, delivery coordination, device-use education, and – if they choose to participate – treatment reminders and educational support during the first six months of therapy. Patients using other eligible specialty pharmacies may have access to similar support, which may vary by pharmacy. Electronic Health Record (EHR) support materials and a step-by-step Getting Started Guide will help providers navigate the process from prescription submission through therapy initiation. Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI IQLIK is the first-of-its-kind anti-amyloid treatment worldwide offering at-home dosing for initiation and maintenance (approved in the U.S.). LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's global placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Clarity AD evaluated lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897). 95% of patients who completed the core study (18 months) chose to continue in the long-term extension study (LTE), with 478 patients still receiving treatment for four years. In the Clarity AD core clinical study, data showed LEQEMBI IV significantly slowed disease progression at 18 months (27% vs placebo), and the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. LEQEMBI also rapidly reduced plaque as early as three months (-59.1 CL difference vs placebo in amyloid level at 18 months; P<0.00001). Additionally, LEQEMBI continued to show benefit over a four-year LTE treatment period; in a subgroup analysis, 81 percent of LEQEMBI patients who stayed on treatment remained in the early AD stages at four years. Over three years of treatment, including both the core study and the LTE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four-year mark. In Clarity AD, the most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

CORE Biomedicine announced a licensing agreement with Eisai Co., Ltd., granting CORE exclusive global rights to develop and commercialize multiple preclinical oncology programs. The licensed programs were originally discovered through research activities conducted by Eisai and its affiliates. Under the agreement, CORE has obtained exclusive, global rights to certain preclinical oncology programs that target key molecular drivers of various cancers. The licensed portfolio includes multiple programs spanning distinct targets and biological pathways.

Eisai Co., Ltd., ¥ 80.0, Cash Dividend, Sep-29-2026

BioArctic AB's partner Eisai announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik) as a starting dose for the treatment of early Alzheimer's disease. The US launch is planned for late August 2026. Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance. It is administered via an autoinjector, offering a convenient alternative to intravenous (IV) infusion from the start of treatment. For initiation, the approved regimen is 500 mg once weekly, delivered as two 250 mg injections, each administered in approximately 15 seconds. Leqembi Iqlik is already approved for maintenance dosing in the US at 360 mg once weekly, once 18 months of IV or subcutaneous treatment has been completed. Patients can now receive Leqembi either as an IV infusion or as a subcutaneous injection (SC) with Leqembi Iqlik throughout the entire treatment course - from initiation through maintenance and may switch between administration methods as needed, providing greater flexibility and convenience. Leqembi is indicated in the US for the treatment of adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. MCI due to Alzheimer's disease represents the earliest symptomatic stage of the disease and may be associated with subtle changes in memory, thinking, language, or daily functioning. The FDA approval of Leqembi Iqlik for treatment initiation is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and dosing regimens. Data from sub-studies within the Phase 3 Clarity AD long-term extension (LTE), conducted following the 18-month core study in individuals with early Alzheimer's disease, showed: Once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, supporting similar clinical (efficacy) and biomarker (amyloid removal) benefits. The rate of exposure-related adverse events such as ARIA-E with SC administration is expected to be comparable with IV administration. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for Leqembi compared to placebo. The overall safety profile of SC administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous Leqembi, most of which were localized, while systemic reactions were less frequently observed. The approval of Leqembi Iqlik as a subcutaneous starting dose provides patients and care partners with the only at-home administration option throughout the Alzheimer's disease treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may: Reduce the burden of clinic visits for patients and care partners; Reduce reliance on infusion and associated healthcare resources; Decrease treatment preparation and administration time, and nursing monitoring requirements; Preserve infusion capacity for patients who prefer or require intravenous therapy. Insights from an autoinjector acceptability study indicated that 94% of patients with early Alzheimer's disease and their care partners found the Leqembi Iqlik device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting. Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (A). Leqembi is approved in 53 countries and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries, including the United Kingdom, China, the US and Japan, and applications have been filed in 12 countries and regions. In the US, Leqembi Iqlik is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Leqembi was included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

BioArctic AB's partner Eisai presented results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study showing that nearly 83% of patients with early Alzheimer's disease enrolled in the study remained stable (75.9%) or improved (6.6%) while receiving Leqembi over an average of 17 months. The results were consistent across sex, race, ethnicity and APOE genotype. The data were presented during the session "Developing Topics Session #3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings" at the Alzheimer's Association International Conference 2026 in London. These findings support long-term benefits of continuous treatment with Leqembi and provide important insights into treatment experience outside of a clinical trial setting. The three-year LEADER study is a multicenter, retrospective real-world study designed to examine Leqembi utilization, treatment persistence, transition to maintenance therapy, safety, cognitive and functional assessments, and healthcare professional implementation learnings in diverse US clinical settings for patients with early Alzheimer's disease. The study integrated deidentified chart and electronic medical record (EMR) data from 13 US sites, healthcare professional surveys and healthcare professional interviews. This interim analysis included 432 patients with early Alzheimer's disease who received at least seven Leqembi infusions as of May 2026. Patient characteristics at baseline: Mean age: 74 years; Female Patients: 55.8%. Disease stage at baseline: Mild cognitive impairment due to Alzheimer's disease: 63.9%; Mild Alzheimer's disease dementia: 36.1%. The mean duration of Leqembi treatment was 520 days. The mean number of Leqembi doses was 26. Change in disease stage was defined as: Stable: Patient remaining in the same disease stage (mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia) from baseline throughout the course of Leqembi treatment. Improvement: Patient transitioning from mild Alzheimer's disease dementia at baseline to mild cognitive impairment due to Alzheimer's disease over the course of Leqembi treatment. Progression: Patient advancing from mild cognitive impairment at baseline to mild/moderate Alzheimer's disease dementia or from mild Alzheimer's disease dementia at baseline to moderate Alzheimer's disease dementia throughout the course of Leqembi treatment. Of the 432 participants enrolled in the LEADER Study, disease stage could be evaluated in 427. Among these patients with early Alzheimer's disease, 82.5% remained stable or improved while receiving Leqembi, with consistent results across sex, race, ethnicity, and APOE genotype groups. 75.9% remained stable compared with baseline, meaning they remained in the same disease stage throughout treatment. 6.6% improved from baseline, moving from mild Alzheimer's disease dementia to mild cognitive impairment due to Alzheimer's disease. Nearly 87% of patients chose to remain on Leqembi treatment. In analyses by APOE e4 status, clinician-evaluated stable or improved disease stage was observed in: 81.7% of APOE e4 heterozygotes (stable: 73.8%; improved: 7.9%); 81.0% of APOE e4 homozygotes (stable: 75.9%; improved: 5.2%). Of the 432 participants in the LEADER study, 155 transitioned to once-every-four-weeks intravenous maintenance treatment, and 14 transitioned to once-weekly subcutaneous maintenance treatment. Among the 155 participants who transitioned to intravenous maintenance therapy, nearly 81% remained stable (72.3%) or improved (8.4%). Of the 14 patients who transitioned to subcutaneous maintenance treatment, 12 (85.7%) maintained their disease stage. Overall safety observations in this real-world study were consistent with the US FDA-approved label. Amyloid-related imaging abnormalities (ARIA) was observed in 12.3% of patients overall; ARIA-E was observed in 6.3% and ARIA-H in 7.9% and isolated ARIA-H in 6.0%. Most ARIA cases were asymptomatic and mild in radiographic severity. No new ARIA-E events, macrohemorrhages or intracerebral hemorrhages greater than 1cm were reported during once-every-four-weeks intravenous maintenance therapy. APOE e4 status safety observations were consistent with the overall cohort and the US FDA-approved label.

Eisai Co., Ltd. and Biogen Inc. announced that results from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study show that nearly 83% of early Alzheimer's disease (AD) patients enrolled in the study remained stable (75.9%) or improved (6.6%) while receiving LEQEMBI therapy over an average of 17 months. The results were consistent across sex, race, ethnicity and APOE genotype. The data was presented during the "Developing Topics Session #3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings" at the Alzheimer's Association International Conference (AAIC) 2026 in London and online. LEQEMBI targets the underlying pathology of the disease and works in two ways throughout treatment - by removing insoluble (plaque) and soluble amyloid beta (protofibrils), helping to slow cognitive decline and loss of daily functioning. Data show continued treatment with LEQEMBI may be able to help keep patients in early AD for longer. Early AD includes mild cognitive impairment (MCI) due to AD and mild AD dementia. The three-year LEADER Study is a multicenter, retrospective real-world study designed to examine LEQEMBI utilization, treatment persistence, transition to maintenance therapy, safety, cognitive and functional assessments, and healthcare professional (HCP) implementation learnings in diverse U.S. clinical settings for patients with early Alzheimer's disease (AD). The study integrated deidentified chart and electronic medical record (EMR) data from 13 U.S. sites, HCP surveys and HCP interviews. This interim analysis included 432 patients with early AD who received at least seven LEQEMBI infusions as of May 2026. The mean age was 74 years and 55.8% were female. Disease stage at baseline was mild cognitive impairment (MCI) due to AD for 63.9% and mild AD dementia for 36.1%. The mean duration of LEQEMBI treatment was 520 days and the mean number of LEQEMBI doses was 26. Change in disease stage was defined as stable (patient remaining in the same disease stage from baseline throughout the course of LEQEMBI treatment), improvement (patient transitioning from mild AD dementia at baseline to MCI due to AD over the course of LEQEMBI treatment), and progression (patient advancing from MCI at baseline to mild/moderate AD dementia or from mild AD dementia at baseline to moderate AD dementia throughout the course of LEQEMBI treatment). Of the 432 participants enrolled in the LEADER Study, disease stage could be evaluated in 427. Among these patients with early Alzheimer's disease, 82.5% remained stable or improved while receiving LEQEMBI, with consistent results across sex, race, ethnicity, and APOE genotype groups. 75.9% remained stable compared with baseline, meaning they remained in the same disease stage throughout treatment. 6.6% improved from baseline, moving from mild AD dementia to MCI due to AD. Nearly 87% of patients chose to remain on LEQEMBI treatment. In analyses by APOE e4 status, clinician-evaluated stable or improved disease stage was observed in 81.7% of APOE e4 heterozygotes (stable: 73.8%; improved: 7.9%) and 81.0% of APOE e4 homozygotes (stable: 75.9%; improved: 5.2%). Of the 432 participants in the LEADER Study, 155 transitioned to once-every-four-weeks intravenous (IV) maintenance treatment, and 14 transitioned to once-weekly subcutaneous (SC) maintenance treatment. Among the 155 participants who transitioned to IV maintenance therapy, nearly 81% remained stable (72.3%) or improved (8.4%). Of the 14 patients who transitioned to SC maintenance treatment, 12 (85.7%) maintained their disease stage. Overall safety observations in this real-world study were consistent with the U.S. FDA-approved label. ARIA (amyloid-related imaging abnormalities) was observed in 12.3% of patients overall; ARIA-E was observed in 6.3% and ARIA-H in 7.9% and isolated ARIA-H in 6.0%. Most ARIA cases were asymptomatic and mild in radiographic severity. No new ARIA-E events, macrohemorrhages or intracerebral hemorrhages greater than 1 cm were reported during once-every-four-weeks IV maintenance therapy. APOE e4 status safety observations were consistent with the overall cohort and the U.S. FDA-approved label. ARIA-E was observed in 5.3% of APOE e4 noncarriers, 6.1% of APOE e4 heterozygotes and 10.3% of APOE e4 homozygotes. ARIA-H was observed in 12.1%, 4.8% and 12.1%, respectively. In APOE e4 homozygotes, no severe ARIA was reported, and all graded ARIA cases were mild to moderate in radiographic severity. Antithrombotic therapy, including anticoagulants or antiplatelet medications, was used by 106 patients, representing 24.5% of the study population. Of these, 11 patients were receiving an anticoagulant, either alone or with an antiplatelet medication, and 95 patients were receiving antiplatelet therapy only. Among patients receiving antithrombotic therapy, the incidence of ARIA was not meaningfully different from that observed in patients not receiving antithrombotic therapy. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved LEQEMBI IQLIK, the subcutaneous autoinjector formulation of lecanemab, for use as maintenance treatment in August 2025 and as initiation treatment on July 13, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing.

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (brand name: LEQEMBI IQLIK®) as an initiation dose for the treatment of early Alzheimer's disease. LEQEMBI IQLIK is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) dosing from the start of treatment. For initiation, the approved regimen is 500 mg given once weekly as two 250 mg injections, each delivered in approximately 15 seconds. LEQEMBI IQLIK may also be used for maintenance dosing at 360 mg once weekly after 18 months of IV or subcutaneous treatment. Throughout the entire treatment course – from initiation through maintenance – patients may receive LEQEMBI either as IV infusion or as subcutaneous (SC) injection with LEQEMBI IQLIK. Patients may also switch from IV to SC administration, or vice versa, providing greater convenience and flexibility in LEQEMBI administration. LEQEMBI is indicated in the United States for adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. MCI due to AD is the earliest symptomatic stage of Alzheimer's disease and can appear with subtle symptoms such as forgetfulness, confusion, or feeling at a loss for words. The FDA approval of LEQEMBI IQLIK as an initiation dose is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and a range of dosing regimens. Sub-studies within the Phase 3 Clarity AD long-term extension (LTE), following the 18-month core study in individuals with early Alzheimer's disease, showed: Once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, supporting similar clinical (efficacy) and biomarker (amyloid removal) benefits. The rate of exposure-related adverse events such as ARIA-E with SC administration is expected to be comparable with IV administration. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for LEQEMBI compared to placebo. The overall safety profile of SC administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed. The approval of LEQEMBI IQLIK as a subcutaneous initiation dose provides patients and care partners with the only at-home administration option throughout the Alzheimer's disease treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may: Reduce the burden of clinic visits currently associated with anti-amyloid therapy for patients and care partners; Reduce reliance on infusion and associated healthcare resources; Decrease treatment preparation and administration time, and nursing monitoring requirements; Preserve infusion capacity for patients who prefer or require intravenous therapy. Insights from an autoinjector acceptability study indicated that 94% of patients with early Alzheimer's disease and their care partners found the LEQEMBI IQLIK device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting. The LEQEMBI CompanionTM program offers help with understanding insurance coverage and potential out-of-pocket costs, and identifying financial support programs, including the LEQEMBI Copay Assistance Program for eligible patients. Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured patients, who meet financial need and other program criteria. LEQEMBI IQLIK for initiation dosing is expected to be available in late August 2026 in the U.S. LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. LEQEMBI® is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause ARIA, characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. Serious intracerebral hemorrhages (ICH) >1 cm, some of which have been fatal, have been observed with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy to a patient being treated with LEQEMBI. Apolipoprotein E e4 (ApoE e4) Homozygotes: Patients who are ApoE e4 homozygotes (~15% of patients with AD) treated with this class of medications have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA. Consider the benefit of LEQEMBI for the treatment of AD and the potential risk of serious ARIA events when deciding to initiate treatment with LEQEMBI. Contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients. Reactions have included angioedema and anaphylaxis. Medications in this class, including LEQEMBI, can cause ARIA-E, which can be observed on MRI as brain edema or sulcal effusions, and ARIA-H, which includes microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with AD, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (CAA), such as pretreatment microhemorrhage or superficial siderosis. ARIA-H generally occurs with ARIA-E. Reported ARIA symptoms may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms usually resolve over time. Symptomatic ARIA occurred in 3% and serious ARIA symptoms in 0.7% with LEQEMBI. Clinical ARIA symptoms resolved in 79% of patients during the period of observation.

Eisai Co., Ltd. announced the latest findings on etalanetug (development code: E2814) showed that this investigational anti-MTBR antibody reduced levels of plasma eMTBR-tau243, a key biomarker of Alzheimer's disease (AD) tau tangle pathology. The investigational compound etalanetug may have the potential to bind to the microtubule-binding region (MTBR) of tau protein and prevent the seeding and propagation of tau pathology in the brain. Tau tangles are a hallmark of AD and are believed to be strongly associated with memory loss, cognitive decline, and disease progression. The findings were presented during the Featured Research Session, "Mechanisms Beyond Amyloid: Etalanetug Reduces Tau Tangle-Specific Plasma Biomarker eMTBR-tau243 in Dominantly Inherited Alzheimer's Disease (DIAD)," at the Alzheimer's Association International Conference 2026 in London and online. The highly sensitive blood biomarker assay measuring eMTBR-tau243 was developed as a potential alternative for cerebrospinal fluid (CSF) and Positron Emission Tomography (PET) testing. This analysis evaluated changes in plasma tau biomarkers following etalanetug administration and compared them with changes observed in CSF biomarkers in individuals with DIAD enrolled in the Phase Ib/II Study 103 (NCT04971733). Etalanetug reduced CSF eMTBR-tau243 by 62% at three months and by 89% at nine months. Etalanetug reduced plasma eMTBR-tau243 by 78% at 3 months and by more than 90% at 9 months, indicating that plasma eMTBR-tau243 closely mirrored disease-related changes captured in CSF. Plasma phosphorylated tau (p-tau217, p-tau181, and p-tau231) and t-tau increased after etalanetug administration in both individuals with DIAD and healthy adults. This change is considered to be attributable to non-CNS tau species derived from peripheral tissues being stabilized by binding to etalanetug in plasma, thereby inhibiting their degradation. Plasma eMTBR-tau243 was largely absent in healthy adults and detected only in patients with DIAD, suggesting it reflects disease-related tau pathology. Administration of etalanetug reduced levels of this biomarker. These results suggest that plasma eMTBR-tau243, unlike plasma phosphorylated tau species and t-tau, is a biomarker that captures disease-specific pathological changes originating from tau pathology in the brain. Etalanetug reduced multiple CSF phosphorylated tau species and t-tau in patients with DIAD. Among these, p-tau205 is a marker reflecting late-stage tau pathology (T2 biomarker) in the Alzheimer's Association guidelines. These findings represent the first report of an anti-tau therapy reducing CSF p-tau205 in patients with DIAD. These results highlight that etalanetug acts on tau pathology in the brain, one of the underlying pathologies of AD. Plasma eMTBR-tau243 may serve as a practical, less invasive biomarker that captures AD-specific pathological changes and may play an important role in the future clinical development of etalanetug. eMTBR-tau243 is a novel fluid biomarker consisting of tau fragments that include tau protein amino acid residue 243 and MTBR, with endogenous cleavage at the C-terminal side of residue 256. It is thought to arise during the formation of neurofibrillary tangles, a key pathological feature of AD, and a strong correlation has been shown between tau PET and eMTBR-tau243 in both plasma and CSF. Etalanetug is an anti-MTBR (microtubule-binding region) tau antibody discovered through collaborative research between Eisai and University College London. It is designed to inhibit the propagation of tau seeds within the brain. Etalanetug is being developed as a potential disease-modifying therapy for tauopathies, including sporadic Alzheimer's disease (AD). Currently, etalanetug is being evaluated in two ongoing clinical studies: the Tau NexGen Phase II/III trial in dominantly inherited Alzheimer's disease (DIAD), conducted under the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) and led by Washington University School of Medicine in St. Louis, added to the standard-of-care anti-Ab protofibril antibody lecanemab (brand name: LEQEMBI), and the Phase II Study 202, a global randomized trial in individuals with early sporadic AD, also assessing etalanetug added to lecanemab. In September 2025, etalanetug received Fast Track designation from the U.S. Food and Drug Administration (FDA). Phase 1b/2 Study 103 is an open-label study evaluating the safety, tolerability, and effects of etalanetug on tau-related biomarkers in cerebrospinal fluid (CSF) in participants with dominantly inherited Alzheimer's disease (DIAD).

Eisai Co., Ltd. and Biogen Inc. announced that new data presented at the Alzheimer's Association International Conference 2026 in London support that the LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration for people with early Alzheimer's disease. The lecanemab subcutaneous auto-injector (SC-AI) was developed to provide a more convenient alternative to intravenous (IV) dosing from the initiation of treatment. This session presented data from the lecanemab SC-AI development program in early Alzheimer's disease, including pharmacokinetic (PK), pharmacodynamic (PD), efficacy, safety and real-world patient and care partner experience findings. Results showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved intravenous (IV) initiation regimen (10 mg/kg every two weeks), supporting the expectation of similar clinical efficacy and safety, independent of the route of administration. If approved by the United States Food and Drug Administration, subcutaneous dosing for initiation may offer a convenient at-home alternative to IV infusion which could support access and delivery of care across healthcare settings. Once-weekly 500 mg SC-AI demonstrated bioequivalence to the IV initiation regimen (10 mg/kg every two weeks), with an exposure ratio of 104% (90% confidence interval: 99.1%–109%). Exposure remained consistent across body weight quartiles, demonstrating a stable pharmacokinetic profile in a broad patient population. Amyloid removal measured by amyloid PET, clinical efficacy measured by CDR-SB, and the incidence of ARIA-E were driven by lecanemab exposure rather than route of administration. The 500 mg SC-AI initiation regimen achieved exposure comparable to the IV initiation regimen, supporting the expectation of a comparable efficacy and safety profile despite the different route of administration. The 500 mg SC-AI initiation regimen demonstrated consistent exposure, amyloid clearance as measured by amyloid PET, clinical efficacy and safety across body weight groups. In addition, amyloid clearance and clinical outcomes were not meaningfully affected by body weight, supporting the appropriateness of a fixed-dose regimen. Patients may also switch from IV to SC administration, or vice versa, and if a dose is missed patients can take it the next day or up to day six providing greater convenience and flexibility in LEQEMBI administration. Overall safety profile of SC-AI was generally consistent with that observed for the IV formulation. Incidence of ARIA-E with the 500 mg SC-AI initiation regimen was predicted to be similar to that observed with the IV initiation regimen. Injection-related reactions were observed with subcutaneous LEQEMBI, most of which were localized, while systemic reactions were less frequently observed. The incidence of anti-drug antibodies (ADA) was low, at 1.4% in the 500 mg SC-AI group. No neutralizing antibodies were observed, confirming that the low immunogenicity profile was maintained with the SC-AI formulation. Data from two U.S. Alzheimer's treatment centers provide early insight into clinical trial and real-world use of subcutaneous LEQEMBI. At Alzheimer's Research and Treatment Center, 28 patients receiving SC administration demonstrated slower cognitive decline as measured by CDR-SB over 36 months relative to a matched Alzheimer's Disease Neuroimaging Initiative natural history cohort. The cohort included 25 patients newly initiated on SC administration and 3 patients who transitioned from IV administration. In a separate case series from First Choice Neurology and Visionary Investigators Network, 10 of 11 evaluable patients (91%) showed improvement or remained stable on MMSE compared with baseline before maintenance therapy. At this center, patients who had received maintenance therapy with SC administration for at least 6 months were included in the analysis. Patient and care partner surveys in these two sites demonstrated high satisfaction with subcutaneous LEQEMBI administration, with satisfaction rates ranging from 75% to 97%, convenience ratings from 83% to 97%, and willingness to recommend treatment ranging from 92% to 100%. Results presented in this session further reinforce the importance of early and continuous treatment, highlighting how LEQEMBI SC initiation and maintenance administration provides greater optionality for long-term disease management. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous maintenance dosing with treatment every four weeks was approved in 8 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions.

BioArctic AB's partner Eisai will present new clinical and real-world evidence on lecanemab (Leqembi) at the Alzheimer’s Association International Conference (AAIC) in London, July 12–15, including data on its subcutaneous formulation, long-term use across diverse patient groups, maintenance dosing, and at-home administration. BioArctic will also participate in the Plenary Session “Prevalence of Alzheimer’s Disease Pathology in the Community,” taking place on 14 July (11:00am to 12:15pm BST). In a presentation called “Outcomes of Clinical Progression for Clinical Trials of People with Neuronal Synucleinopathy with Cognitive Impairment”, strategies for assessing clinical progression in people with cognitive impairment related to a-synuclein pathology will be discussed, primarily across Parkinson’s disease, Parkinson’s disease dementia, and dementia with Lewy bodies. Key oral lecanemab presentations at AAIC include subcutaneous treatment data, emerging clinical evidence and practical use considerations for the subcutaneous formulation of lecanemab, including clinical trial and real-world patient experience. The LEADER study – real-world evidence from US clinical practice, as part of the “Featured Research Session: Lecanemab Three Years Post Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings”, will present data from the LEADER study evaluating real-world lecanemab use in diverse US clinical settings three years post-approval, including results on maintenance dosing with IV treatment every four weeks and the first reported findings of at-home subcutaneous administration. Presentations on the Phase 3 AHEAD 3-45 study in preclinical Alzheimer’s Disease will highlight progress of the trial, including updates on participant retention and engagement. Additional oral presentations include “Treatment Actions following ARIA in Patients Treated with Lecanemab: Evidence from a Post-Marketing Observational Study in Japan”, “Sex-Based Outcomes of Lecanemab in Early Alzheimer’s Disease: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER)”, “External Controls in Open-Label Extensions: Insights from Clarity AD”, “Broad Modulation of Core Tau Biomarkers, Including pTau205 Following Lecanemab Treatment”, “Tau PET Change in CLARITY-AD”, “Racial And Ethnic Differences in %p-tau217 Associations with Cognitive Performance and Amyloid PET In Preclinical AD”, and “Lecanemab Clinical Practice: A Multicenter, Surveillance Safety Study from the ALZ-NET Registry”. Poster presentations on lecanemab include “Characterization and Utilization Assessment of a Centrally Supported Ride-Share Service Implemented in a Multisite Preclinical Alzheimer’s Clinical Trial”, “Long-Term Persistence and Patient Characteristics for Intravenous and Subcutaneous Lecanemab in Real-World Use in the United States”, “Retrospective Case Series of Real-world Clinical and Patient-reported Outcomes with Lecanemab”, “Retrospective Observational Cohort Study of Real-world Clinical and Patient-reported Outcomes with Lecanemab”, “Subcutaneous Lecanemab Administration in an Alzheimer’s Disease Treatment Center: Real-World Clinical Outcomes and Patient Experiences”, “INITIATE-SC: A Multicenter Real-World Study of Subcutaneous Lecanemab Initiation in Early Alzheimer’s Disease”, “Continued or Time-limited Treatment Benefits of Anti-amyloid Monoclonal Antibodies In Early Alzheimer’s Disease”, “Early Alzheimer’s Disease Treated with Lecanemab: A Real-World, Retrospective Analysis from a Colorado Neurological Clinic”, “Communicating Participant Milestones to Enhance Trial Engagement and Retention in a Preclinical Alzheimer’s Trial”, “Initial Real-World Experience in Using Lecanemab in Hong Kong: Safety and Preliminary PET CT Data”, “Real-World Lecanemab Treatment in Early Alzheimer’s Disease: A Retrospective Dementia Clinic Case Series Review from a Geriatric Medicine Clinical Practice”, “A Time and Motion and Patient Satisfaction Study of Subcutaneous Injection of Lecanemab for Patients with Early Alzheimer’s Disease”, “Differential Costs Of Amyloid-related Imaging Abnormality Management Between Anti-amyloid Treatments: Estimates Based On A Delphi Panel”, “VISION AD-JP: A Prospective Multicenter Real-world Study of Japanese Patients with Early Alzheimer’s Disease Treated with Lecanemab”, “Real-World Outcomes with Lecanemab Treatment in a New England Alzheimer’s Disease Center”, “Estimating the Economic Impact of Delayed Alzheimer's Disease Progression with Lecanemab”, and “Economic, Health, and Quality-of-Life Burden on Caregivers and Study Partners of Lecanemab-Treated Individuals with Alzheimer’s Disease”. Eisai-Sponsored Symposium is intended for HCPs only, with the title “Early Intervention in Alzheimer’s Disease: Building the Evidence from Pathology to Practice”. Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Leqembi is approved in 53 countries and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries, including the United Kingdom. The sBLA has been assigned an extended PDUFA date of August 24, 2026. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai’s Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer’s disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer’s disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer’s disease, that is conducted by Dominantly Inherited Alzheimer Network Trials Unit, led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd. announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency has accepted for evaluation a marketing authorization application for its in-house-discovered and developed orexin receptor antagonist lemborexant for the treatment of adult patients with insomnia, characterised by symptoms present for at least 3 months with considerable impact on daytime functioning. Lemborexant is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep and wake states by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). Lemborexant acts on the orexin neurotransmitter system, which regulates wakefulness. Lemborexant is believed to facilitate sleep onset and decrease wakefulness during the night by blocking the orexin receptors. Lemborexant, an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Fast on/off receptor kinetics of lemborexant to orexin receptors may influence lemborexant's potential to facilitate improvements in sleep onset and maintenance with minimal morning residual effects. It has been approved for the treatment of insomnia in over 25 countries including Japan, the United States, Canada, Australia, and China, among others.

Eisai Co Ltd. announced the company would present the latest findings from its Alzheimer’s disease (AD) research, including lecanemab (brand name: LEQEMBI), its anti-amyloid beta (Aß) protofibril antibody for the treatment of Alzheimer’s disease (AD), and anti-MTBR (microtubule binding region) tau antibody, etalanetug (E2814), at the Alzheimer’s Association International Conference 2026 (AAIC) from July 12-15 in London and online. Eisai will present 52 abstracts across its AD portfolio at AAIC. Highlights include a Developing Topics Session and a Featured Research Session on lecanemab, featuring four and six oral presentations, respectively, alongside 10 additional key oral presentations and 32 posters. Eisai will also host a symposium on early intervention in AD. A Developing Topics Session will feature emerging clinical evidence and practical use considerations for the subcutaneous formulation of lecanemab, including clinical trial and real-world patient experience. Presentations on the Phase 3 AHEAD 3-45 study in preclinical AD will highlight progress of the trial including updates on participant retention and engagement. Additional oral presentations will highlight a Phase 2 trial of etalanetug with background lecanemab, and the effect on tau pathology. Eisai will present findings on the subcutaneous formulation of lecanemab in early Alzheimer’s disease, including safety profile, clinical outcomes, and patient experience from an Alzheimer’s disease treatment center, as well as real-world patient-reported outcomes with subcutaneous lecanemab treatment in early Alzheimer’s disease in the United States. The LEADER study will provide a three-year update of lecanemab in early Alzheimer’s disease, including use and clinical outcomes by APOE e4 status, concomitant medications, sex, race, and ethnicity, real-world use of lecanemab once-monthly maintenance dosing, the first reported findings of at-home subcutaneous lecanemab administration, real-world insights on lecanemab maintenance therapy patient pathway, and physician and perceived patient satisfaction with lecanemab maintenance therapy. Additional presentations will cover treatment actions following ARIA in patients treated with lecanemab, sex-based outcomes of lecanemab in early Alzheimer’s disease, external controls in open-label extensions, broad modulation of core tau biomarkers including pTau205 following lecanemab treatment, tau PET change in CLARITY-AD, racial and ethnic differences in %p-tau217 associations with cognitive performance and amyloid PET in preclinical AD, lecanemab clinical practice from the ALZ-NET Registry, baseline imaging characteristics of participants in a Phase 2 trial of etalanetug and concurrent lecanemab, etalanetug and tau tangle specific plasma eMTBR-tau243 in DIAD, refining plasma pTau217/Aß42 cutoffs for amyloid positivity in an Asian cohort with high cerebrovascular disease burden, and more. Poster presentations will include characterization and utilization assessment of a centrally supported ride-share service implemented in a multisite preclinical Alzheimer’s clinical trial, long-term persistence and patient characteristics for intravenous and subcutaneous lecanemab in real-world use in the United States, retrospective case series of real-world clinical and patient-reported outcomes with lecanemab, retrospective observational cohort study of real-world clinical and patient-reported outcomes with lecanemab, subcutaneous lecanemab administration in an Alzheimer’s disease treatment center, INITIATE-SC multicenter real-world study of subcutaneous lecanemab initiation in early Alzheimer’s disease, continued or time-limited treatment benefits of anti-amyloid monoclonal antibodies in early Alzheimer’s disease, real-world analysis from a Colorado neurological clinic, communicating participant milestones to enhance trial engagement and retention in a preclinical Alzheimer’s trial, initial real-world experience in using lecanemab in Hong Kong, real-world lecanemab treatment in early Alzheimer’s disease from a geriatric medicine clinical practice, time and motion and patient satisfaction study of subcutaneous injection of lecanemab, differential costs of amyloid-related imaging abnormality management between anti-amyloid treatments, VISION AD-JP prospective multicenter real-world study of Japanese patients with early Alzheimer’s disease treated with lecanemab, real-world outcomes with lecanemab treatment in a New England Alzheimer’s disease center, estimating the economic impact of delayed Alzheimer’s disease progression with lecanemab, economic, health, and quality-of-life burden on caregivers and study partners of lecanemab-treated individuals with Alzheimer’s disease, surrogate antibody of etalanetug and uptake of tau monomer and aggregate in human macrophages, novel CSF eMTBR-tau243 immunoassay for detecting AD tau pathology and assessing etalanetug pharmacodynamics in DIAD, blood-based biomarkers in early Alzheimer’s disease, confirmatory blood-based biomarkers and diagnostic timing in Alzheimer’s disease, practical factors influencing the use of confirmatory blood-based biomarkers in Alzheimer’s care, frontline perspectives on the real-world use of blood-based biomarkers in Alzheimer’s disease, evolution of real-world blood-based biomarker use in the lecanemab patient pathway, retrospective analysis of costs of amyloid diagnostic tests for Alzheimer’s disease, piloting digital cognitive assessments and a blood-based biomarker to improve Alzheimer’s disease diagnosis, real-world diagnostic pathways for Alzheimer’s disease in U.S. clinical practice, integrated peptide-level global proteomics and co-expression network analysis, proteomic assessment of CSF biomarkers of neurodegeneration from a minimally invasive and serial CSF collection technique in mice, driving time to infusion sites as an obstacle to receiving Alzheimer’s treatments, treatment goals for anti-amyloid therapy in early-AD, and interpreting evidence for self-administered digital cognitive assessments. South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

University College London and Eisai Co., Ltd. have signed a new agreement to extend their long-standing collaboration in drug discovery and development for five more years, taking the partnership through to 2030. This alliance reinforces a unique model built on trust, combining academic excellence with industry expertise to accelerate innovation in neuroscience drug discovery, investigating new ways of treating neurodegenerative diseases such as Alzheimer’s, Parkinson’s, Amyotrophic Lateral Sclerosis and other related disorders. One of the most notable outcomes of the University College London–Eisai Co., Ltd. collaboration to date is the anti-MTBR tau antibody E2814, which was first discovered as part of collaborative research between the two organisations. The antibody is currently being evaluated in the DIAN-TU Phase II/III Clinical trial for Dominantly Inherited Alzheimer’s Disease (DIAD), as well as the Phase II clinical trial for sporadic early AD (Study 202). In total, eight drug discovery projects focusing on a variety of therapeutic targets have been supported through a GBP 10 million investment to date, with further investment committed over the next five years as part of the extension. These efforts are underpinned by a strong commitment to knowledge exchange, reflected in more than 30 scientific outputs including publications and presentations to date, ensuring jointly acquired insights are shared with the wider community, and helping to move the field closer to delivering meaningful outcomes for patients. The renewed agreement launches with collaborative projects targeting novel therapeutic pathways while opening the door to University College London researchers across disciplines to bring forward innovative ideas for co-development. Over the next five years, the alliance will focus on: Moving promising collaborative projects through recognised stage gates of the drug development pathway; Actively seeking and advancing high-potential drug discovery projects to tackle neurodegeneration; Strengthening the neurodegeneration research talent pipeline by creating specialist scientist roles across joint projects; Enabling researchers to publish and present findings to the wider scientific community, including at international conferences; Sustaining close engagement at every level, from senior leadership to project scientists, across both organisations. First launched in 2012 and spearheaded by the University College London Translational Research Office and the Faculty of Brain Sciences, the Eisai–University College London alliance exemplifies a bespoke partnership model that goes beyond traditional academia-industry collaborations. Over the past decade, it has created a dynamic ecosystem that accelerates translational research towards the clinic, nurtures early-stage projects, connects scientific pain points with the right expertise and invests in talent development through initiatives such as jointly funded PhDs and long-term knowledge sharing between the organisations.

Eisai Co., Ltd. Presents at Alzheimer’s Association International Conference (AAIC Meeting) 2026, Jul-12-2026 through Jul-15-2026. Venue: London, United Kingdom. Presentation Date(s): Jul-12-2026. Jul-13-2026. Jul-14-2026.

Beren Therapeutics P.B.C. announced that it has received a round of funding on June 10, 2026.

Eisai Co., Ltd. has completed a Fixed-Income Offering. Security Name: 2.614% Straight Bonds due June 10, 2033 Security Type: Corporate Bond/Note (Non Convertible) Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Eisai Co., Ltd. has completed a Fixed-Income Offering in the amount of ¥200 million. Security Name: 3.022% Notes due June 10, 2036 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: ¥200 million Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Eisai Co., Ltd. has completed a Fixed-Income Offering in the amount of ¥20 billion. Security Name: 2.226% Straight Bonds due June 10, 2031 Security Type: Corporate Bond/Note (Non Convertible) Principal Amount: ¥20 billion Price\Range: 100% Security Features: Unsecured Coupon Type: Fixed

Eisai Co., Ltd. announced that it has determined the terms and conditions for the issuance of its 8th, 9th and 10th series of unsecured straight bonds (with limited inter-bond pari passu clause) as outlined below. The bond issuance is intended to support Eisai s medium- to long-term growth investments by securing stable funding and maintaining financial flexibility, while further diversifying its financing sources. Eisai intends to use the proceeds from the offering for working capital, including research and development expenses for priority development products, investments in licensed-in products, and repayment of short-term debt. The 8th Series of Eisai Co., Ltd. Unsecured Straight Bonds, the 9th Series of Eisai Co., Ltd. Unsecured Straight Bonds, and the 10th Series of Eisai Co., Ltd. Unsecured Straight Bonds are being issued with the following details: the maturity periods are 5 years for the 8th Series, 7 years for the 9th Series, and 10 years for the 10th Series. The issue amounts are JPY 20 billion for the 8th Series, JPY 10 billion for the 9th Series, and JPY 20 billion for the 10th Series. The denomination of each bond is JPY 100 million. The interest rates are 2.226% per annum for the 8th Series, 2.614% per annum for the 9th Series, and 3.022% per annum for the 10th Series. The issue price for all three series is 100.00% of the principal amount. The redemption price is also 100.00% of the principal amount. The maturity dates are June 10, 2031 for the 8th Series, June 10, 2033 for the 9th Series, and June 10, 2036 for the 10th Series. Interest payment dates are June 10 and December 10 of each year, with the initial interest payment date being December 10, 2026. The method of offering is public offering. The pricing date is June 4, 2026, and the issue date is June 10, 2026.

Eisai Co., Ltd. announced dividend for the Fiscal Year Ended March 31, 2026 and Provided Dividend Guidance for Second Quarter- End and Fiscal Year Ending March 31, 2027. For the Fiscal Year Ended March 31, 2026, the company announced dividend of JPY 80.00 per share compared to JPY 80.00 per share a year ago. Expected date of ordinary general meeting of shareholders: June 17, 2026, Expected date of dividend payment commencement: June 1, 2026. For the second quarter- end, the company expects dividend of JPY 80.00 per share compared to JPY 80.00 per share a year ago. For the Fiscal Year- end, the company expects dividend of JPY 80.00 per share compared to JPY 80.00 per share a year ago.

Eisai Co., Ltd. provided consolidated earnings guidance for the full year ending March 31, 2027. For the full year, the company expected revenue of JPY 883,500 million, operating profit of JPY 70,000 million, profit for the year of JPY 54,000 million, profit attributable to owners of parent of JPY 52,300 million and earnings per share attributable to owners of the parent of JPY 185.00.

Eisai Co., Ltd. provided earnings guidance for the fiscal year 2026 (April 2026 to March 2027). For the year, company issued a new forecast with expected sales of JPY 143.5 billion, representing 63% growth year-on-year.

Eisai Co., Ltd. reported earnings results for the full year ended March 31, 2026. For the full year, the company reported sales was JPY 825,378 million compared to JPY 789,400 million a year ago. Net income was JPY 38,558 million compared to JPY 46,432 million a year ago. Basic earnings per share from continuing operations was JPY 136.78 compared to JPY 163.76 a year ago.

Eisai Co., Ltd., Annual General Meeting, Jun 17, 2026, at 10:00 Tokyo Standard Time. Location: Tokyo Garden Theater 2-1-6 Ariake Koto-Ku Tokyo Japan Agenda: To consider the contents of the business report, consolidated financial statements, and audits of the consolidated financial statements conducted by the Accounting Auditor and the Audit Committee for the 114th Fiscal Year (from April 1, 2025, to March 31, 2026); to consider the contents of the financial statements for the 114th Fiscal Year (from April 1, 2025, to March 31, 2026); to consider appointment of 12 Directors; and to consider other matters.

Eisai Co., Ltd., Board Meeting, May 15, 2026. Agenda: To discuss the resolution was adopted for the disposal of treasury stock in connection with the continuation of the System and the Trust; to The System adopts a scheme known as the Officers Compensation BIP Board Incentive Plan Trust For the operation of the System from the 2026 fiscal year onward, the trust period of the established Trust will be extended; and to consider the other matters if any.

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI IQLIK) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of LEQEMBI IQLIK as a starting dose. Eisai and Biogen believe that the comprehensive clinical data package evaluating subcutaneous administration of LEQEMBI across multiple studies and dosing regimens strongly supports the potential use of LEQEMBI IQLIK for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025. LEQEMBI has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. LEQEMBI (lecanemab-irmb) is available: Intravenous infusion: 100 mg/mL; Subcutaneous injection: 200 mg/mL. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd. announced that they will report Q1, 2027 results at 3:30 PM, Tokyo Standard Time on Aug 03, 2026

Eisai Co., Ltd. Presents at Fierce Biotech Week 2026, May-12-2026 02:15 PM. Venue: Boston, Massachusetts, United States. Speakers: Priya Chaturvedi.

Eisai Co., Ltd. reported preliminary sales results for the first quarter 2026. For the quarter, the company reported total sales of JPY 26.2 billion.

Eisai Co., Ltd., 2026 Earnings Call, May 15, 2026

Eisai Co., Ltd. announced that they will report fiscal year 2026 results at 3:30 PM, Tokyo Standard Time on May 15, 2026

Eisai Co., Ltd. has filed a Shelf Registration in the amount of ¥300 billion. Security Name: Bonds Principal Amount: ¥300 billion

Eisai Co., Ltd. and MSD K.K. announced that an application for LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, has been submitted in Japan for the additional dosage and administration in combination with WELIREG (belzutifan), the first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor from MSD, for the treatment of unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy. This application is based on the results of the Phase 3 LITESPARK-011 trial evaluating the dual regimen of LENVIMA plus WELIREG for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), the LENVIMA plus WELIREG combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the primary endpoints, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. The safety profile of this combination was consistent with those reported for each agent administered as monotherapy, and no new safety signals were identified. LENVIMA is approved in combination with KEYTRUDA (pembrolizumab) in Japan for the first-line treatment of unresectable or metastatic RCC. WELIREG is approved in Japan for the treatment of unresectable or metastatic RCC that has progressed following cancer chemotherapy. Additionally, supplemental New Drug Applications (sNDA) for the LENVIMA and WELIREG combination therapy for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PD-L1 inhibitor has been accepted by the U.S. Food and Drug Administration (FDA), with a PDUFA (Prescription Drug User Fee Act) target action date set for October 4, 2026. LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRa), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below. Thyroid cancer - Indication as monotherapy (Approved mainly in Japan, the United States, Europe, China and Asia) Japan: Unresectable thyroid cancer The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC) Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI) Hepatocellular carcinoma - Indication as monotherapy (Approved mainly in Japan, the United States, Europe, China and Asia) Japan: Unresectable hepatocellular carcinoma The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy - Indication in combination with KEYTRUDA (generic name: pembrolizumab) and transarterial chemoembolization (Approved in China) Thymic carcinoma - Indication as monotherapy (Approved in Japan) Japan: Unresectable thymic carcinoma Renal cell carcinoma (In Europe other than the United Kingdom, the agent was launched under the brand name Kisplyx) - Indication in combination with everolimus (Approved mainly in the United States, Europe and Asia) The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy - Indication in combination with KEYTRUDA (Approved mainly in Japan, the United States, Europe and Asia) Japan: Radically unresectable or metastatic renal cell carcinoma The United States: The first-line treatment of adult patients with advanced renal cell carcinoma Europe: The first-line treatment of adult patients with advanced renal cell carcinoma Endometrial carcinoma - Indication in combination with KEYTRUDA (Approved mainly in Japan, the United States, Europe and Asia) Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy The United States: The treatment of patients with advanced endometrial carcinoma that is pMMR or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery.

BioArctic's AB partner Eisai presented new data at the 2026 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PDTM), held in Copenhagen, Denmark March 17-21. Eisai presented new real-world findings from an analysis of long-term treatment persistence among early Alzheimer's disease patients in the United States receiving intravenous (IV) lecanemab. Based on data from the PurpleLab CLEAR Claims database, the analysis showed that most patients continued lecanemab therapy after the initial 18 months of treatment (78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months). The results are similar to what was seen in the Phase 3 Clarity AD study where 94% of patients who completed 18 months of lecanemab treatment chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE study, patients who stayed on treatment continued to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer's disease (ADNI). Professor Lars Lannfelt, BioArctic's co-founder, delivered an oral presentation about the binding profile of lecanemab in Alzheimer's disease brain tissue, demonstrating its selective targeting of soluble amyloid-beta (Aß) protofibrils. He described the mechanisms of action, showing how lecanemab engages immune pathways to promote clearance of Aß. Ebba Amandius from BioArctic also presented a poster that showed the successful use of a screening strategy in the ongoing exidavnemab trial in Parkinson's disease and multiple system atrophy (EXIST), applying alpha-synuclein seed amplification assay (SAA) for patient stratification between placebo and treatment arms. The approach enabled even distribution of participants with alpha-synuclein pathology between arms while still allowing timely randomization. It highlights the feasibility and importance of SAA testing during screening in clinical trials targeting alpha-synuclein. Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval. Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Leqembi is approved in 53 countries and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 7 countries, including the United Kingdom, China, the US and Japan, and applications have been filed in 10 countries and regions. In the US, Leqembi Iqlik is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Leqembi was included in the Commercial Insurance Innovative Drug List, recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, Eisai's supplemental Biologics License Application regarding a subcutaneous starting dose with Leqembi Iqlik was granted Priority Review by the US FDA with a May 24, 2026, PDUFA date. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd. and Biogen Inc. announced that new real-world findings from an analysis of long-term treatment persistence and baseline characteristics among people receiving intravenous (IV) lecanemab (generic name, brand name LEQEMBI), an anti-amyloid-ß (Aß) protofibril antibody, showed that most patients continue with ongoing lecanemab therapy after the initial 18 months of treatment. The analysis was presented at the 20th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PDTM 2026) in Copenhagen, Denmark, and online. Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD study chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE of the Clarity AD study, patients continue to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer's disease (Alzheimer's Disease Neuroimaging Initiative: ADNI*). This analysis is the first time real-world lecanemab data on treatment persistence beyond 18 months has been reported. This study was a retrospective observational analysis using the PurpleLab® CLEAR Claims database, a comprehensive dataset based on medical insurance claims across the United States and was conducted to evaluate the long-term treatment persistence of lecanemab in real-world clinical practice. The analysis population consisted of 10,763 individuals who met the requirement for continuous healthcare encounters, out of the 13,388 individuals recorded in the database who received at least one IV treatment with lecanemab between January 6, 2023 and November 30, 2025. At baseline, the mean age was 73.8 years and 56.5% were female. The most common comorbidities were dyslipidemia (42.2%) and hypertension (36.9%). The mean follow-up duration was 350.9 days. The average number of administrations was 1.7 per month, and the mean dosing interval was 16.4 days (median 14 days), which was generally consistent with the recommended every two weeks dosing. The time-dependent proportion of patients who remained on lecanemab treatment was evaluated using the Kaplan-Meier method in a subgroup of 371 patients who initiated treatment in 2023 and had 20 months of continuous follow-up, thereby enabling assessment of long-term treatment persistence beyond 18 months. As a result, 78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. Of the 78.4% of patients who remained on lecanemab at 18 months, the majority of them continued treatment during the maintenance period beyond 18 months, confirming a high rate of treatment persistence with lecanemab in real-world clinical practice. The patient characteristics and dosing patterns observed in this claims-based analysis were generally similar to those reported in the Clarity AD study. Furthermore, the relatively high treatment adherence observed among individuals suggests that potential delays due to MRI monitoring requirements, adverse events, and other factors did not substantially affect lecanemab dosing. Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 10 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A Supplemental Biologics License Application (sBLA) for initiation treatment was accepted in January 2026. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, Lecanemab (IV) has been included in the 'Commercial Insurance Innovative Drug List', recently introduced by the National Healthcare Security Administration (NHSA) of China. In the global Phase 3 placebo-controlled, double-blind, parallel-group, randomized Clarity AD core study, the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. Over three years of treatment, including both the core study and the OLE, data showed lecanemab demonstrated a reduction in cognitive decline-measured by CDR-SB-of 1.01 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER** cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four years mark. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of soluble Aß, having a primary role in the cognitive decline associated with this progressive, debilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aß plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.

Eisai Co., Ltd. has announced the establishment of Eisai Global Capability Centre (EGCC) within Eisai Knowledge Centre, India, in Visakhapatnam (Vizag), Andhra Pradesh, India. The opening ceremony was held today, marking the commencement of its operation. The Centre serves as Eisai s information technology hub. The establishment of EGCC represents a core initiative of Eisai Groups long-term IT strategy. By integrating external expertise and technologies, the EGCC insources the design and operation of internal information technology services. This, in turn, enables delivery of standardized high quality information technology services in a secure environment, strongly supporting Eisai Groups global business operations. With the EGCC taking the lead in global IT functions, Eisai will transition its organizational structure, allowing regional IT functions to focus more on strategic business transformation aligning with their region-specific operations. In its initial phase, the EGCC will focus primarily on standardizing global IT infrastructure operations. The Centre plans to gradually expand its scope to include cybersecurity, data & analytics, and operational applications, in response to business needs. Eisai established Eisai Knowledge Centre, India, in Andhra Pradesh in 2009. Since then the facility has served as a core operational hub for global production and process research, while also contributing to employment creation in the local area. Andhra Pradesh is currently spearheading initiatives to establish a New IT City by designating Special Economic Zone (SEZ), attracting data centers and AI hubs, and aiming to create 300,000 IT jobs. By establishing the EGCC within the Eisai Knowledge Centre, India, the company aim to recruit and nurture excellent global IT human resource who resonates with human health care (hhc) concept. Through long-term employment and career development opportunities, the company will contribute to the development of the local IT ecosystem and economic prosperity.

Eisai Co., Ltd. and Biogen Inc. announced that new real-world findings from an analysis of long-term treatment persistence and baseline characteristics among people receiving intravenous (IV) lecanemab (generic name, brand name LEQEMBI®), an anti-amyloid-ß (Aß) protofibril antibody, showed that most patients continue with ongoing lecanemab therapy after the initial 18 months of treatment. The analysis was presented at the 20th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online. In real-world clinical practice, patients with chronic diseases who stay on their treatments longer tend to experience better clinical outcomes and higher satisfaction. Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD study chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE of the Clarity AD study, patients continue to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer's disease (Alzheimer's Disease Neuroimaging Initiative: ADNI*). This analysis is the first time real-world lecanemab data on treatment persistence beyond 18 months has been reported. This study was a retrospective observational analysis using the PurpleLab® CLEAR Claims database, a comprehensive dataset based on medical insurance claims across the United States and was conducted to evaluate the long-term treatment persistence of lecanemab in real-world clinical practice. The analysis population consisted of 10,763 individuals who met the requirement for continuous healthcare encounters, out of the 13,388 individuals recorded in the database who received at least one IV treatment with lecanemab between January 6, 2023 and November 30, 2025. At baseline, the mean age was 73.8 years and 56.5% were female. The most common comorbidities were dyslipidemia (42.2%) and hypertension (36.9%). The mean follow-up duration was 350.9 days. The average number of administrations was 1.7 per month, and the mean dosing interval was 16.4 days (median 14 days), which was generally consistent with the recommended every two weeks dosing. The time-dependent proportion of patients who remained on lecanemab treatment was evaluated using the Kaplan–Meier method in a subgroup of 371 patients who initiated treatment in 2023 and had 20 months of continuous follow-up, thereby enabling assessment of long-term treatment persistence beyond 18 months. As a result, 78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. Of the 78.4% of patients who remained on lecanemab at 18 months, the majority of them continued treatment during the maintenance period beyond 18 months, confirming a high rate of treatment persistence with lecanemab in real-world clinical practice. The patient characteristics and dosing patterns observed in this claims-based analysis were generally similar to those reported in the Clarity AD study. Furthermore, the relatively high treatment adherence observed among individuals suggests that potential delays due to MRI monitoring requirements, adverse events, and other factors did not substantially affect lecanemab dosing. Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 10 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A Supplemental Biologics License Application (sBLA) for initiation treatment was accepted in January 2026. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, Lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In the global Phase 3 placebo-controlled, double-blind, parallel-group, randomized Clarity AD core study, the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. Over three years of treatment, including both the core study and the OLE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer's Disease Neuroimaging Initiative (ADNI) cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER** cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four years mark. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd. Presents at AD/PD Conference 2026, Mar-17-2026 . Venue: Copenhagen, Denmark.

To present our medium- to long-term value creation strategy

FierceBiotech, Fierce Biotech Week 2026, May 12, 2026 through May 14, 2026. Venue: Boston, Massachusetts, United States.

Eisai Co., Ltd. announced that it has received an orphan drug designation for its in-house discovered and developed novel selective orexin 2 receptor agonist E2086, with prospective indication for narcolepsy, from the Ministry of Health, Labour and Welfare (MHLW). Narcolepsy is a chronic sleep disorder that is characterized by excessive daytime sleepiness (EDS). Due to problems with fatigue, cognition, and persistence of residual symptoms despite treatment, disease burden for narcolepsy is high, and narcolepsy remains a disease with high unmet medical needs. While estimates vary depending on the study data, a 2025 report estimates the narcolepsy patient population in Japan to be approximately 46,000. Narcolepsy is classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). The pathogenesis of narcolepsy type 1 is thought to involve a deficiency of orexin due to autoimmune destruction of orexin-producing neurons located in the hypothalamus. Although the pathogenesis of narcoleps type 2 remains unknown, it has been suggested that a reduction in orexin neurotransmission may also be involved. Orexin is a neurotransmitter that plays a central role in regulating sleep and wakefulness. Inhibiting orexinergic neurons is believed to promote a natural transition from wakefulness to sleep. Conversely, activating orexinergic neurons is believes to help maintain a more stable state of wakefulness. From the perspective of inhibiting orexinergic neuron activity, Eisai has developed the insomnia treatment DAYVIGO®? (generic name: lemborexant), an orexin receptor antagonist that is approved in more than 25 countries and regions worldwide. Furthermore, leveraging the unique orexin platform established through the development of DAYVIGO, Eisai has created E2086, a selective orexin 2 receptor antagonist that activates orexinergic neurons. Eisai has the potential to improve patients' symptoms by enhancing orexin receptor activity and acting on the pathophysiology of narcolepsy. Eisai presented data from a Phase Ib clinical study in patients with narcolepsy type 1, which suggests that E2086 has the potential to improve daytime wakefulness, at the World Sleep 2025 congress.4. Eisai considers neurology, including sleep- wakefulness, including sleep- wakefulness and narcolepsy, as a therapeutic area of focus. Eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families.

Alzheimer's Disease and Related Disorders Association, Inc., Alzheimer’s Association International Conference (AAIC Meeting) 2026, Jul 12, 2026 through Jul 15, 2026. Venue: London, United Kingdom.

Eisai Co., Ltd. reported earnings results for the nine months ended December 31, 2025. For the nine months, the company reported sales was JPY 619,950 million compared to JPY 601,164 million a year ago. Net income was JPY 41,808 million compared to JPY 45,484 million a year ago. Basic earnings per share from continuing operations was JPY 148.31 compared to JPY 160.14 a year ago.

Eisai Co., Ltd., Board Meeting, Feb 09, 2026. Agenda: To consider Appointment of Corporate Officers.

The Kenes Group Holding Company, AD/PD Conference 2026, Mar 17, 2026 through Mar 21, 2026. Venue: Copenhagen, Denmark.

Eisai Limited is disappointed by Canada'sDrug Agency (CDA-AMC)'s recommendation to not publicly reimburse DAYVIGO (lemborexant) for the treatment of chronic insomnia disorder (CID), characterized by difficulties with sleep onset and/or maintenance occurring at least three nights per week for a minimum of three months. This is the second time CDA-AMC has made this recommendation. In the most recent submission, Eisai submitted real-world clinical evidence demonstrating the benefit of DAYVIGO for patients and the healthcare system. Additionally, extensive patient and clinician input was provided supporting the benefits of DAYVIGO, representing 90 clinicians and four patient organizations. Despite the new evidence and overwhelming stakeholder support, reimbursement was not recommended by CDA. The implications are significant: lack of public coverage for innovative therapies like DAYVIGO creates inequities and forces patients and clinicians to choose ineffective or harmful alternatives. This recommendation perpetuates a cycle of inadequate care and unmet need for millions of Canadians struggling with insomnia who have to rely on treatments not intended for long-term use. Furthermore, this recommendation perpetuates the use of treatments which contradict Canadian expert consensus recommendations that support the value of DAYVIGO in addressing a critical gap in chronic insomnia care.1 The Canadian consensus indicates that Dual Orexin Receptor Antagonists (DORAs) such as DAYVIGO improve sleep outcomes, with no marked rebound or withdrawal signs or symptoms when treatment is discontinued, suggesting an improved safety profile compared to commonly prescribed insomnia medications. The CDA's recommendation leaves clinicians' hands tied, forcing reliance on outdated and off-label treatments with well-documented safety risks – risks that CDA itself has acknowledged. DAYVIGO, amongst a class of medications known as DORAs, targets the brain's wake system to encourage natural sleep without dependence, rebound insomnia, or next-day impairment. This innovative mechanism allows patients to achieve deeper, longer-lasting sleep without compromising next-day functioning. The pivotal SUNRISE 1 and 2 studies provide the strongest evidence to date, backed by five years of safety data. These studies confirm its efficacy and safety for long-term use, with limited observed physical dependence, withdrawal symptoms, or tolerance. Approved by Health Canada in November 2020, DAYVIGO remains accessible only to those with private coverage or who can pay out of pocket. Currently publicly funded options in Canada, namely benzodiazepines and Z-drugs (such as zopiclone), are neither indicated nor recommended for long-term use to treat CID. Health Canada advises limiting use of these medications to just seven to ten consecutive days; however, long-term public reimbursement continues, potentially perpetuating dependence, cognitive decline, and preventable accidents. Continued reliance on older therapies prolongs potential harm, especially in the more vulnerable populations who are reliant on the publicly funded drug programs such as seniors and those on social assistance. Canadian consensus recommendations identify cognitive behavioral therapy for insomnia (CBT-I), followed by DORAs, as the most suitable evidence-based approach for managing chronic insomnia. Eisai fully endorses CBT-I as the first-line treatment; however, access to CBT-I remains limited and inequitable across Canada, a gap acknowledged recently by CDA in its review of quetiapine for insomnia care.3 For patients who cannot access CBT-I, or for whom CBT-I alone is insufficient, DAYVIGO provides a clinically meaningful and safe alternative. Eisai remains steadfast in commitment to ensuring that individuals living with chronic insomnia have access to safe and effective treatment options. Guided by human health care (hhc) mission, Eisai will continue working to close these gaps in care and ensure Canadians living with chronic insomnia receive the treatment they need.

BioArctic AB's (publ) partner Eisai announced that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting dose has been granted Priority Review by the U.S. Food and Drug Administration (FDA). Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early Alzheimer's disease). A Prescription Drug User Fee Act (PDUFA) action date is set for May 24, 2026. If approved, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease. Should the FDA approve the Leqembi Iqlik 500 mg subcutaneous (SC) dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The injection time for each Leqembi Iqlik autoinjector takes approximately 15 seconds per each 250 mg injection. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall Alzheimer's disease treatment pathway. The sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity Alzheimer's disease open-label extension (OLE) following the 18-month core study in individuals with early Alzheimer's disease. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection or infusion-related reactions. Alzheimer's disease is a progressive, relentless disease, with amyloid beta (Aß) and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils (PF) that begins before amyloid plaque removal and continues afterward. Only Leqembi fights Alzheimer's disease in two ways – targeting both PF and amyloid plaque, which can impact tau downstream.

BioArctic AB's (publ) partner Eisai announced that they have submitted a proposed Marketing Authorisation Variation to the European Medicines Agency (EMA) for a once every four weeks intravenous (IV) infusion maintenance dosing for lecanemab. In the EU, lecanemab is indicated for the treatment of patients with a clinical diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (early Alzheimer's disease) who are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes with confirmed amyloid pathology. Lecanemab is currently licensed as an IV infusion with a dosing regimen of once every two weeks (10 mg/kg). Eisai's submission states that following the initial dosing regimen of Once every two weeks, after 18 months, patients will be transitioned to the maintenance dosing regimen of once every four weeks. Treatment with lecanemab should be discontinued once the patient progresses to moderate Alzheimer's disease. Lecanemab are the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) andinsoluble forms of amyloid-beta (Ab). Lecanemab is approved in 53 countries and is under regulatory review in 7 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and other countries, and applications have been filed in 4 countries and regions. In the U.S., Leqembi Iqlik(TM) is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease (AD). In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with Leqembi IqlIK was also completed and a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Lecanemab has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, Eisai's supplemental Biologics License Application regarding a subcutaneous starting dose with Leqembi IQLik was granted Priority Review by the US FDA with a May 24, 2026, PDUFA date. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd., Q3 2026 Earnings Call, Feb 09, 2026

Eisai Co., Ltd. expected to report Fiscal Year 2026 results on May 15, 2026. This event was calculated by S&P Global (Created on January 7, 2026).

BioArctic AB's (publ) partner Eisai announced that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of Leqembi (lecanemab) for treatment of early Alzheimer's disease has been accepted by the National Medical Products Administration (NMPA) in China. If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for this progressive, relentless disease. If approved, the SC-AI of 500 mg could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting. The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway. Similar applications for initiation dosing with subcutaneous injection of lecanemab was recently submitted to the U.S. Food and Drug Administration (FDA) and to Japan'sPharmaceuticals and Medical Devices Agency (PMDA). Leqemab has previously been approved for subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease in the United States under the brand name Leqembi Iqlik(TM). Eisai estimates that there were 17 million patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease in China in 2024, which is expected to increase with the aging of the population. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) andinsoluble forms of amyloid-beta (Ab). Leqemab is approved in 52 countries and is under regulatory review in 8 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and other countries, and applications have been filed in 4 countries and regions. In the U.S., Leqembi IqlIK(TM) is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease (AD). In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with Leqembi was also completed and a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, lecanemab has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the National Institutes of Health.

BioArctic AB's (publ) partner Eisai presented the latest findings on time saved with continued treatment with lecanemab (Leqembi®) at the 18th Clinical Trials in Alzheimer's Disease (CTAD) conference, held in San Diego December 1-4. Data suggests potential to delay disease progression from Mild cognitive impairment (MCI) to moderate Alzheimer's disease (AD) by up to 8.3 years in the low-amyloid group who started treatment at an early stage. Additionally, a scientific symposium was held on the subcutaneous formulation with an autoinjector (SC-AI), which was approved for maintenance treatment in the United States in August 2025, and the rolling supplemental Biologics License Application (sBLA) for initiation treatment was completed in November 2025. The application for a subcutaneous injectable formulation in Japan was submitted in November 2025. Real-world data from different clinics and countries were also presented at the congress, demonstrating continued clinical benefit with lecanemab treatment and a safety profile consistent with the phase 3 Clarity AD study. Based on data from the Clarity AD open-label extension (OLE) and 16 clinical studies of monoclonal antibodies for Alzheimer's disease (AD), this analysis estimated long-term disease progression over 10 years and the slowing effect of continued lecanemab treatment. The analysis evaluated estimated "time savings" (slowing of disease progression) compared to natural decline based on ADNI[1] (Alzheimer's Disease Neuroimaging Initiative) data (untreated group), using Clinical Dementia Rating - Sum of Boxes (CDR-SB). These results suggest that early initiation and long-term lecanemab treatment may continue to slow AD progression and help maintain cognitive function over a longer period. Time Savings from Mild Cognitive Impairment (MCI) Due to AD to Mild AD; The time to progression from MCI due to AD to mild AD was 7.2 years in the untreated group, whereas with continued Leqembi treatment to the onset of moderate AD, progression to mild AD took 9.7 years, indicating a time savings of 2.5 years. In the low-amyloid group (patients who started treatment at an early stage: amyloid PET <60 centiloids), the time to progression from MCI to mild AD was 13.2 years with continued Leqembi treatment to the onset of moderate AD, suggesting a time savings of 6.0 years. Time Savings from MCI due to AD to Moderate AD; The time to progression from MCI due to AD to moderate AD was 10.1 years in the untreated group, whereas with continued Leqembi treatment to the onset of moderate AD, progression to moderate AD took 13.6 years, indicating a time savings of 3.5 years. In the low-amyloid group, the time to progression with continued Leqembi treatment to the onset of moderate AD was 18.4 years, suggesting a time savings of 8.3 years. These findings indicate that earlier initiation of Leqembi treatment may provide a greater delay in disease progression. Furthermore, each additional year on Leqembi could further delay disease progression compared to stopping treatment, even long after plaque is expected to have been cleared. Based on clinical data and modeling analysis, the effect on amyloid removal in the brain and safety (ARIA-E incidence) was shown to be independent of the route of administration and explained by exposure, suggesting that weekly 500 mg SC dosing provides similar efficacy and safety to biweekly 10 mg/kg IV dosing. Additionally, ARIA-E incidence was also predicted to be comparable between SC and IV administration (12.4% overall, 30.9% in ApoE4 homozygotes). In this sub-cohort which had prior exposure to lecanemab, safety evaluation showed systemic infusion reactions occurred in 0% of patients receiving 500 mg SC, all of whom had previously received IV lecanemab. For patients who initiated treatment on 720 mg lecanemab SC by vial, 1.4% showed systemic infusion reactions. This should be compared with systemic infusion reactions of 26.4% in those treated with IV. Immunogenicity assessment indicated a low incidence of anti-drug antibodies (ADA) at 1.4%. These results indicate that the subcutaneous formulation of lecanemab, designed with consideration for the convenience of patients and their care partners, maintains efficacy with a low incidence of systemic infusion reactions, and is otherwise equivalent to conventional IV administration.

Eisai Co., Ltd. and Biogen Inc. announced that the latest findings on time savings with continued treatment with humanized anti-soluble aggregated amyloid-beta (Ab) monoclonal antibody lecanemab (generic name, U.S. brand name LEQEMBI®) were presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference. Additionally, a scientific symposium was held on the subcutaneous formulation (SC-AI), which was approved for maintenance treatment in the United States in August 2025, and the rolling supplemental Biologics License Application (sBLA) for initiation treatment was completed in November 2025. The application for a subcutaneous formulation in Japan was submitted in November 2025. This analysis used data from the Clarity AD open-label extension (OLE) and 16 clinical studies of monoclonal antibodies for AD to estimate long-term AD progression over 10 years and the slowing effect of continued lecanemab treatment. The analysis evaluated estimated "time savings" (slowing of disease progression) compared to natural decline based on ADNI** (Alzheimer's Disease Neuroimaging Initiative) data (untreated group), using Clinical Dementia Rating - Sum of Boxes (CDR-SB). These results suggest that early initiation and long-term lecanemab treatment may continue to slow AD progression and help maintain cognitive function over a longer period. Findings from each group: Time Savings from Mild Cognitive Impairment (MCI) Due to AD to Mild AD. The time to progression from MCI due to AD to mild AD was 7.2 years in the untreated group, whereas with continued LEQEMBI treatment to the onset of moderate AD, progression to mild AD took 9.7 years, indicating a time savings of 2.5 years. In the low-amyloid group (patients who started treatment at an early stage: amyloid PET <60 centiloids), the time to progression from MCI to mild AD was 13.2 years with continued LEQEMBI treatment to the onset of moderate AD, suggesting a time savings of 6.0 years. Time Savings from MCI due to AD to Moderate AD. The time to progression from MCI due to AD to moderate AD was 10.1 years in the untreated group, whereas with continued LEQEMBI treatment to the onset of moderate AD, progression to moderate AD took 13.6 years, indicating a time savings of 3.5 years. In the low-amyloid group, the time to progression with continued LEQEMBI treatment to the onset of moderate AD was 18.4 years, suggesting a time savings of 8.3 years. These findings indicate that earlier initiation of LEQEMBI treatment may provide a greater delay in disease progression. Furthermore, each additional year on LEQEMBI could further delay disease progression compared to stopping treatment, even long after plaque is expected to have been cleared. In this symposium, the latest data from the lecanemab subcutaneous clinical development program were presented focusing on treatment initiation, including results from the subcutaneous (SC) formulation subcohort (n=273) in the Clarity AD trial OLE. It was shown that weekly administration of lecanemab SC-AI at 500 mg (two 250 mg injections) demonstrated bioequivalence in drug exposure compared to intravenous (IV) dosing of 10 mg/kg every two weeks (exposure ratio: 104%, 90% CI: 99.1%–109%). Based on clinical data and modeling analysis, the effect on amyloid removal in the brain and safety (ARIA-E incidence) was shown to be independent of the route of administration and explained by exposure, suggesting that weekly 500 mg SC dosing provides similar efficacy and safety to biweekly 10 mg/kg IV dosing. Additionally, ARIA-E incidence was also predicted to be comparable between SC and IV administration (12.4% overall, 30.9% in ApoE4 homozygotes). In this sub-cohort which had prior exposure to lecanemab, safety evaluation showed systemic infusion reactions occurred in 0% of patients receiving 500 mg SC, all of whom had previously received IV lecanemab, and 1.4% of patients who initiated on 720 mg SC by vial, which is favorable compared to systemic infusion reactions in the IV group (26.4%). Immunogenicity assessment indicated a low incidence of anti-drug antibodies (ADA) at 1.4%. These results indicate that the subcutaneous formulations of lecanemab, designed with consideration for the convenience of patients and their care partners, maintains efficacy with a low incidence of systemic infusion reactions, and is otherwise equivalent to conventional IV administration. Eisai serves as the lead for lecanemab's development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. Protofibrils are thought to be the most toxic Aß species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.3 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aß plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD. ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has filed a new drug application for "LEQEMBI®?" seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S.,China, he United Kingdom, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval.

Eisai Co., Ltd. announced that new data on anti-tau antibody etalanetug (development code: E2814) was presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference. Etalanetug is designed to bind to the microtubule-binding region (MTBR) of tau protein and prevent the seeding and propagation of tau pathology. This presentation is based on the Phase Ib/II study (E2814-103) conducted in individuals (n=7) with dominantly inherited Alzheimer's disease (DIAD). In this study, as previously reported, tau aggregates in the brains of individuals (n=3) were measured using tau PET, and the results showed that the observed tau PET signals were stabilized or trended toward decrease following administration of etalanetug, suggesting that etalanetug inhibited tau propagation and suppressed or reduced the accumulation of tau aggregates in brains. The study evaluated eMTBR-tau243 as a specific biomarker of tau pathology progression and measured changes in cerebrospinal fluid (CSF) and plasma. MTBR-tau243 is a CSF biomarker correlated with tau pathology, and eMT BR-tau243 has also been developed as a highly sensitive biomarker in plasma. eMTBR-tau244 is a novel fluid biomarker consisting of tau fragments that include tau protein amino acid residue243 and MTBR, with endogenous cleavage at the C-terminal side of residue 256. It is thought to arise during the formation of neurofibrillary tangles, a key pathological feature of Alzheimer's disease (AD), and a strong correlation has been shown between tau PET and eMTBR-tau 243 in both plasma and CSF. By using eMTBR-tau242, it becomes possible to easily measure changes in tau pathology using a blood test. Study results show that etalanetug reduced CSF eMTBR-tau241 by 62% at 3 months and by 89% at 9 months. Similarly, plasma eMTBR-tau245 was reduced by 78% at 3 months and over 90% at 9 months. These findings support etalanetug's mechanism of action to inhibit tau seeding and spreading in the brain and encourage further studies to determine its clinical potential as a disease-modifying therapy for AD. Currently, etalanetug is being evaluated in two ongoing clinical studies: the Tau NexGen Phase II/III trial inDIAD, conducted under the Dominantly inherited Alzheimer Network Trials Unit (DIAN-TU) and led by Washington University School of Medicine in St. Louis, added to a standard-of-care anti-Ab protofibril antibody lecanemab as the standard of care.

BioArctic AB's (publ) partner Eisai announced that Leqembi (lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. In August 2024, Leqembi was approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers in the United Kingdom. With this latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks, patients may be transitioned to a maintenance dosing regimen of 10 u/kg once every four weeks, or they may continue with 10 mg/kg once every four weeks. In the United Kingdom, an estimated 982,000 people are living with dementia, with AD accounting for an estimated 60-70% of cases. These numbers are expected to rise as the population ages. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region. Leqembi's approvals in these countries were based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Leqembi Iqlik™? is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease in the US. In September 2025, a rolling sBLA application for the subcutaneous initiation dosing with Leqembi IQLik was also initiated to the U.S. FDA. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3 -45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

BioArctic AB's (publ) partner Eisai announced that they have completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab subcutaneous autoinjector (SC-AI), Leqembi Iqlik, as a weekly starting dose after the FDA granted Fast Track Status. Upon acceptance of the sBLA, the FDA will set a PDUFA date (Prescription Drug User Fee Act) for review completion. If approved for initiation dosing, Leqembi Iqlek would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners to treat this progressive, deadly disease. In the United States, Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The sBLA is supported by data evaluating subcutaneous (SC) administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE) following the 18-month core study in individuals with early AD. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. Subcutaneous administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection/infusion-related reactions. Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly (every two weeks) intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both initial treatment and the currently approved maintenance therapy, offering the option of SC or IV administration throughout the entire treatment journey. The injection time for each Leqembi IqlIK autoinjector takes approximately 15 seconds. Alzheimer's disease is a progressive, deadly disease with amyloid beta (Ab) and tau as hallmarks that is caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward. Leqembi fight Alzheimer's disease in two ways - targeting both amyloid plaque and protofibrils, which can impact tau downstream. Leqembi is currently approved in 51 countries and regions and is under regulatory review in 9 countries. In August 2025, the U.S. FDA approved Leqembi Iqlak 360 mg for weekly subcutaneous maintenance dosing after 18 months of IV treatment every two weeks. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and other countries, and applications have been filed in 4 countries and regions. In the U.S., Leqembi IqlK., Leqembi IQLik is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease. In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with an autoin injector for maintenance treatment of early disease. In November 2025, AHEAD 3-45) with lecanemab in individuals with lecanemab in patients with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. The study was fully recruited In October 2024. AHEAD 3-45 is a four-year study conducted as a four-year study conducted As a four-private partnership between Eisai, the Alzheimer's Clinical Trial Consortium that provides the Alzheimer's Clinical Trial Consortium That provides the U. AHEAD 3-45 are fully recruited in October 2024. AHEAD 3 -45 is a four-45 is a public-private partnership between EisAI.

BioArctic AB's (publ) partner Eisai announced that they have filed a new drug application for Leqembi (lecanemab) for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan'sPharmaceuticals and Medical Devices Agency (PMDA). If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, deadly disease. The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500 mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting. The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway. A similar application for initiation dosing with subcutaneous injection of lecanemab was recently submitted to the U.S. Food and Drug Administration (FDA). Leqembi has previously been approved for subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease in the United States under the brand name Leqembi Iqlik(TM) is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease (AD). In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with Leqembi IqlIK was also completed. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLik in August 2025. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. LEQEMBI IQLK is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Results in early-stageclinical trials may not be indicative of fully results or results from later stage and larger scale clinical trials and do no ensure regulatory approval. The company caution that these statements are subject to risks and uncertainties, many of which are outside of control and could cause future events or results to difference materially from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for existing products, sales, pricing, growth, reimbursement and launch of its marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which it compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbrevi regulatory pathways; ability to effectively implement corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for products and other aspects of business, which are outside of full control; risks related to commercialization of biosimilars, which is subject to such risks related to the reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in o ther potential indications; risks associated with clinical trials, including ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of drug candidates; and the occurrence of adverse safety events, restrictions on use with products, or product liability claims; and any other risks and uncertainties that are described in the U.S. FDA and the U.S. FDA granted Fast Track Status.

BioArctic AB's (publ) partner Eisai will present the latest findings on lecanemab (Leqembi®?) at the Clinical Trials on Alzheimer's Disease (CTAD) conference, being held in San Diego December 1-4. Presentations will include data on long-term treatment and estimated time savings over 10 years, as well as safety and potential benefits of subcutaneous administration of lecanemab for initiation dosing. In addition, data on the effects of lecanemab on soluble amyloid-beta (Ab) protofibrils and insights from real-world clinical practice studies, including the US ALZ-NET registry, will also be presented. Key oral presentations: Continued treatment: On Tuesday, Dec. 2, at 5:05 PM PT and Wednesday, Dec. 3, at 2:40 PM PT, new analyses will be presented on benefits of continued therapy and estimated time savings over 10 year of lecanemab treatment based on Phase 3 clinical data (LB12, LB21). Subcutaneous initiation dosing: On Wednesday, Dec. 3, the late-breaking symposium, "Lecanemab Subcutaneous Formulation for Treatment Initiation in Early Alzheimer's Disease: Optimizing Patient Care with a Potential New Option" (3:10 - 3:50 PM PT), will explore potential benefits of subcutaneous lecanemab initiation dosing as well as pharmacokinetic and safety findings (LB Symposium 2). Real-world experience: A presentation on Thursday, Dec. 4, at 11:40 AM PT will share findings from an interim analysis of a post-marketing observational study of lecanemab in Japan (OC30). Mechanism-related: A presentation scheduled for Tuesday, Dec. 2, in Dec. 2, at 1:40 PM PT, will review the effects of le canemab treatment on soluble Ab protofibrils in the Clarity AD clinical trial (OC5). Key lecanemab poster presentation: Real-world experience: During the poster session on Dec. 1, at 3:00 PM PT and Tuesday, Dec. 2, At 5:30 PM PT, Poster 055 presents an overview of baseline characteristics and preliminary safety findings from a study of lecanemab In Alzheimer's disease (AD) using the ALZ-NET registry. Additional lecanemab poster presentations: Dec. 1 (Mon.) - Dec. 2 (Tues.) Real-world experience: A presented on Dec. 1 (Mon.)-Tues.) Characterizing Enrollment patterns in a Preclinical Alzheimer's Disease Trial (P006); Dec. 1 (Mon.) -- Dec. 2 (Tues) Stability and Improvement in Early Alzheimer's Disease with Lecanemab: Sub-analysis from a United States Multicenter, Retrospective Real-World Study (P049); Dec. 1 (Mon.). - Dec. 2 (Tue.) Long-Term Benefit of Lecanemab in Patients with Low Baseline Amyloid: Estimation of Time Saved (P052); Dec. 1 (Mon.), Dec. 2 (Tues.). Patient, Care Partner, and Health Care Professional Acceptability of the Autoinjector for the Subcutaneous Delivery of Lecanemab In the US (P053). Dec. 1 (Mon.).

Vivacta Biotechnology (Shanghai) Co., Ltd. announced that it has received more than CNY 100 million in round of funding led by new investor Qiming Weichuang Venture Capital Management (Shanghai) Company Limited on November 6, 2025.The transaction included the participation from, Apricot Capital, Beijing Shunxi Venture Capital Fund Management Co.,Ltd., B Capital Group Management, L.P., Eisai Co., Ltd., Xiamen C&D Emerging Industry Equity Investment Co., Ltd., Hankang Capital, Shanghai Wei Run Ze Management Consulting Center (Limited Partnership) and individual investors. The company issued convertible preferred stock in the transaction.

BioArctic AB's (publ) partner Eisai announced that Leqembi (lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. In August 2024, Leqembi was approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers in the United Kingdom. With this latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks, patients may be transitioned to a maintenance dosing regimen of 10 mg and 10 mg/kg once every four weeks, or they may continue with 10 mg/kg once every two weeks. In the United Kingdom, an estimated 982,000 people are living with dementia with AD accounting for an estimated 60-70% of cases. These numbers are expected to rise as the population ages. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and inoluble forms of amyloid-beta (Ab). Leqembi is approved in 51 countries including the U.S., Japan, China, and the European Union for the treatment of Alzheimer's disease (AD) In patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) and is under regulatory review in 9 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance Dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and others, and applications have been filed in 4 countries and regions. Leqembi's approvals in these countries were based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Leqembi Iqlik(TM) is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease in the US. In September 2025, a rolling sBLA application for the subcutaneous initiation dosing with Leqembi IqlIK was also initiated to the U.S. FDA. Since July 2020, Eisai'sPhase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

to present the FY2025 Opinion Exchange Meeting on the Value Creation Report and ESG

Eisai Co., Ltd. announced that the Company had entered into a settlement agreement (the Settlement) with generic drug manufacturer Torrent Pharmaceuticals Ltd. (Torrent), on November 6, 2025 regarding a lawsuit filed in the U.S. District Court for the District of New Jersey for infringement of patents relating to Lenvima (generic name: lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor discovered by the Company (U.S. Patent Nos. 10,407,393 and 11,186,547; collectively ‘the Patents’). Torrent had submitted an Abbreviated New Drug Application (ANDA) for a generic version of Lenvima. Under the settlement agreement, Torrent will be permitted to launch its generic lenvatinib product in the United States as of July 1, 2030, unless certain defined contingencies occur earlier than that date. The settlement will be effective after the Consent Judgement is entered by the Court. The Patents are directed to highly pure lenvatinib and have been asserted in other patent infringement litigations. Previously, the Company settled patent infringement lawsuits regarding ANDA submissions with SUN Pharmaceutical Industries Ltd. and SUN Pharmaceutical Industries Inc. (collectively SUN Pharma) on March 21, 2024, and with Dr. Reddy s Laboratories, Ltd. and Dr. Reddy s Laboratories Inc. (collectively Dr. Reddy s) on September 22, 2025. Under those settlement agreements, both SUN Pharma and Dr. Reddy s will be permitted to launch its generic lenvatinib product in the United States as of July 1, 2030, unless certain defined contingencies occur earlier than that date. Additionally, the Company received a favorable decision on May 28, 2025, against generic drug manufacturer Shilpa Medicare Limited (Shilpa) in the lawsuit filed in the U.S. District Court for the District of New Jersey. Based on that decision, Shilpa is not able to receive approval from the U.S. Food and Drug Administration (FDA) to sell its generic lenvatinib product until after the 547 Patent and related exclusivity expires in February 2036.

Eisai Co., Ltd., ¥ 80.0, Cash Dividend, Mar-30-2026

Merck and Eisai announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA®? (pembrolizumab), Merck's anti-PD-1 therapy, plus LENVIMA®? (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as an single agent, is indicated for The treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA- approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumors should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Microsatellite Instability-High or Mismatch Repair Deficient Cancer: KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA- approve test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA is indicated For the treatment of patients with unre intersectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA- approval. Gastric Cancer: KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first -line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L 1 (CPS1) as determined by an FDA -approved test. KEYTRUDA is indicates for the treatment of patients with locally advanced or metastatic esophageal or metastatic junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not enable to surgical resection or definitive che Moradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS1), or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1.

Eisai Co., Ltd. and Biogen Canada Inc. announced that Health Canada has issued a Notice of Compliance with conditions (NOC/c) for humanized anti-soluble aggregated amyloid-beta (Ab) monoclonal antibody "LEQEMBI®" (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes and who have confirmed amyloid pathology. LEQEMBI is the first treatment for early AD that targets an underlying cause of the disease, to be authorized in Canada. The approval of LEQEMBI is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. LEQEMBI has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Eisai plans to submit clinical assessment data captured from participants in real-world clinical practice. LEQEMBI's approvals in these countries was based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all Key secondary endpoints with statistically significant Results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In September 2025, the rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with LEQEM BI IQLIK was also initiated. Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. These statements involve risks and uncertainties that could cause actual results to differ materially from those collected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability and other proprietary rights and challenges; product liability.

Merck and Eisai announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG®? (belzutifan), Merck's first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, plus LENVIMA®? (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, met one of its primary endpoints of progression-free survival (PFS) for the treatment of patients with advanced Renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy. In combination with pembrolizumab, for the treatment of patients With advanced endometrial carcinoma that isismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Across clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA-treated patients. Grade 3-5 arterial thromboembolic events ranged from 2% to 3% across all clinical trials. In DTC, RCC,and HCC clinical trials, hemorrhagic events, of any grade, occurred in 29% of the 799 patients treated with LENVIMA as a single agent or in combination with everolimus. Serious tumor-related bleeds, including fatal hemorrhagic events, occurred in LENVIMA- treated patients in clinical trials and in the postmarketing setting. Safety and effectiveness of LENVIMA in patients with ATC have not been demonstrated in clinical trials. Withhold LENVIMA if ONJ develops and restart based on clinical judgement of adequate resolution. By addressing barriers to clinical trial participation, screening and treatment, the company work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Eisai's focus on cancer Eisai positions Oncology as one of its key strategic areas, and aims to contribute to the cure of cancers through the discovery of innovative new drugs with new targets and mechanisms of action under the Deep Humaniology Learning (DHBL) drug discovery and development organization. R risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; RCC's focus on cancer; and Eisai positions on cancer; Eisai positions Oncologists as one of its key strategic area, and aims to contribute to The cure of cancers through the discovery the discovery of innovative new drugs With new targets and mechanisms of action over the Deep Humaniology Learning (DHBL) drug discovery and development organizations. R risks and uncertainties include and are not limited to, general company conditions and competition; general economic conditions and competition; general economic factor, including interest rate and currency Exchange rate fluctuations; the impact of Pharmaceutical industry regulation and health care legislation In the United States and internationally; Global trends toward health care cost containment, the company expects to contribute to the cure of cancer through the discovery of innovative new drug with new targets and mechanisms of actions under the Deep Humaniology Learning ("DHBL") drug discovery and development organization. Risk and uncertainties include but are not Limited to, general industry conditions and compete; general economic factors, includinginterest rate and currency exchange rate fluctuations.

BioArctic AB's (publ) announced that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Leqembi®? (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes and who have confirmed amyloid pathology. Leqembi is the first treatment for early AD that targets an underlying cause of the disease, to be authorized in Canada. The approval of Leqembi is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. Leqembi has been issued market authorization in Canada with conditions, pending the results of trials to verify its clinical benefit. Eisai plans to submit clinical assessment data captured from participants in real-world clinical practice. Alzheimer's Disease is the most common form of dementia, accounting for 60 to 80% of all cases. Leqembi is approved in the U.S., Japan, EU, China, Great Britain, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Leqembi Iqlik(TM) is approved for subcutaneous injection for maintenance dosing for the treatment of early Alzheimer's disease in the US. In September 2025, a rolling sBLA application for the subcutaneous initiation dosing with Leqembi IQLik was also initiated to the U.S. FDA. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis.

Merck and Eisai announced long-term follow-up data continued to show durable benefit of KEYTRUDA®? (pembrolizumab), Merck's anti-PD-1 therapy, plus LENVIMA®? (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, compared to chemotherapy for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, As a single agent, is indicated For the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA- approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumors should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Microsatellite Instability-High or Mismatch Repair Deficient Cancer: KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA- approve test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA is indicated For the treatment of adults with unresectable or metast metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA- approval test. KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first -line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L 1 (CPS 1) as determined by an FDA -approved test. KEYTRUDA is indicating for the treatment of patients with locally advanced unresectable and metastatic esophageal junction (GE J) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not enable to surgical resection or definitive che Moradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS 1), or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell historical historical and metastatic. KEYTRU DA, as a single agent after one and more prior lines of systemic therapy For patients of squamous cell historical, and metastatic NSCLC, as a single agent after 1 or more prior lines of systemic treatment for patients of squamous cell hist histine kinase inhibitor (Tki) discovered by Eisai.

Eisai Co., Ltd., Q2 2026 Earnings Call, Nov 05, 2025