Corporate Events

Eisai Co., Ltd. Presents at 13th Annual Immuno-Oncology Summit, Aug-13-2025 09:20 AM. Venue: Philadelphia, Pennsylvania, United States. Speakers: Utpal Majumder, Senior Scientist, R&D.

BioArctic AB's (publ) partner Eisai presented the latest findings on lecanemab (Leqembi) at the Alzheimer's Association International Conference, held in Toronto, July 27 to July 31. The presentations included four-year treatment data from the phase 3 Clarity AD open-label extension study, data on subcutaneous dosing and interim data from an ongoing real-world evidence study. The data further reinforces the clinical efficacy of lecanemab, with a safety profile in line with the phase 3 Clarity AD core study results. Four years of lecanemab treatment helped patients remain in early stage of Alzheimer's disease longer compared to natural disease course, with consistent safety profile. In the core phase 3 study of lecanemab in early Alzheimer's disease, Clarity AD, 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, corresponding to a 27% slowing of clinical decline. A change from 0.5 to 1 on the CDR score domains of Memory, Community Affairs and Home/Hobbies reflect a shift from mild impairment to loss of independence. Of the patients who completed the core study, 95% chose to continue in the open-label extension study. Over three years of treatment, including both the core study and the OLE, lecanemab demonstrated 1.01 points less decline, measured by CDR-SB, compared to the Alzheimer's Disease Neuroimaging Initiative. Similar results were observed on the ADAS-Cog14 scale (51% and 51% respectively) and on the ADCS-MCI-ADL scale (64% and 58% respectively). These findings suggest that initiating and maintaining treatment with lecanemab in early-stage Alzheimer's disease may slow clinical decline and offer sustained long-term benefits. No new safety findings were observed in the OLE with continued lecanemab treatment over four years. Furthermore, the interim data showed high retention rates with approximately 87% of patients continuing therapy, as well as safety data in line with the FDA-approved label, with most ARIA cases reported as asymptomatic (1.1% symptomatic ARIA-E and 0% symptomatic ARIA-H). Subcutaneous dosing of lecanemab could offer a new option for treatment of early Alzheimer's disease: Several clinical trials investigating subcutaneous dosing of lecanemib have been conducted, including a sub-study within the open-label extension of the phase 3 Clarity AD study. Data presented at the AAIC demonstrate that transitioning to a weekly 360 mg SC autoinjector dose of lecanemab, following 18 months of initiation dosing with 10 mg/kg (IV) biweekly, maintains clinical and biomarker benefits comparable to continued biweekly intravenous administration. Lecanemab is approved in 46 countries including the U.S., Japan, China, and the European Union for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment or mild dementia stage of disease (collectively referred to as early AD), and is under regulatory review in 10 countries. 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. 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. 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 AD and to confirm the effective of treatments.

Eisai Co., Ltd. and Biogen Inc. announced that results on investigational maintenance therapy with subcutaneous autoinjector (SC-AI) of lecanemab-irmb (U.S. brand name: LEQEMBI®?), an anti-amyloid beta (Ab) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, and virtually. Only lecanemab fights AD in two ways-- targeting both protofibrils and plaque, which can impact tau accumulation downstream. Clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD, to evaluate a range of doses administered by SC vial or autoinjector. The pharmacology (PK/PD), clinical (efficacy endpoints such as CDR-SB) and biomarker (amyloid PET and blood biomarkers) relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option. Additionally, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for the LEQEMBI subcutaneous autoinjecter for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 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. Presents at 2025 Alzheimer’s Association International Conference, Jul-27-2025 through Jul-31-2025. Venue: Toronto, Ontario, Canada. Presentation Date(s): Jul-27-2025. Jul-28-2025. Jul-29-2025. Jul-30-2025.

Eisai Co., Ltd., Q1 2026 Earnings Call, Aug 05, 2025

Cambridge Healthtech Institute, Inc., 13th Annual Immuno-Oncology Summit, Aug 11, 2025 through Aug 13, 2025. Venue: Philadelphia, Pennsylvania, United States.

Eisai Limited has expanded the footprint of its Canadian Headquarters in Mississauga, Ontario. The newly expanded headquarters reflects Eisai's continued investment in Ontario and strengthens its ability to deliver innovative care to patients across the country. Eisai holds a strong history of continued investment in research and development and is focused on pursuing a world free from cancer, Alzheimer's disease and other neurodegenerative conditions. Driven by an ethos to improve patients' lives, Eisai has attracted a Canadian workforce that leads with passion and a connection to the patients serve. With this expansion, Eisai's Canada site has grown to over 100 employees representing a 246% increase since 2020, confirming its commitment to advancing innovative solutions for patients and contributing meaningfully to Canada's health care and life sciences future. Fueled by empathy and curiosity, employees are empowered to venture beyond the familiar, to ask tough questions and make bold moves to deliver breakthrough treatments. Eisai has built strong collaborations with Ontario's post-secondary institutions, offering residency, internship and co-op opportunities that help cultivate the next generation of innovators.

PRISM BioLab Co. Ltd. announced that the analysis of a combination study of E7386, created through collaboration research with Eisai Co. Ltd. ("Eisai"), and Lenvatinib mesylate ("lenvatinib") will be presented by Eisai at the American Society of Clinical Oncology (ASCO) Congress 2025, held in Chicago, USA from May 30 to June 3, 2025. To determine the optimal dose of E7386 in combination with Lenvatinib in the open-label Phase Ib study (NCT04008797), expansion cohort of advanced endometrial cancer patients progressed following platinum-based chemotherapy and anti-PD-(L)1 immunotherapy have been implemented by Eisai and the enrollment of 30 patients was completed. By data cutoff (Oct 22, 2024), with 9 patients remaining on treatment, 30% (9 patients) showed the confirmed response (decrease of tumor size > 30%) for an overall response rate of 30.0%. Furthermore, among patients without prior Lenvatinib treatment, the overall response rate was 42.9%. For the subsequent dose-optimization part for E7386 + LEN in advanced endometrial cancer, enrollment of patients had been initiated (NCT04008797). E7386 is an orally available small molecule CBP/b-catenin inhibitor that inhibits protein-protein interactions between the transcription factor CBP and b-catenin, and regulates the Wnt signaling. E7386 achieved clinical POC (Proof of concept) in October 2021 and following clinical studies are ongoing including phase I for solid tumors as monotherapy, Phase Ib for solid tumors in combination with tyrosine kinase inhibitor Lenvatinib, Phase Ib/II for solid tumors in combination with pembrolizumab, the anti-PD-1 antibody from Merck & Co. Inc., Rahway, NJ, USA. L envatinib is a multi-kinase inhibitor, discovered by Eisai and being co-developed and co-commercialized under a collaboration agreement with Merck & Co. Inc. Rahway, NJ, USA, which inhibits vascular endothelial growth factor receptors (VEGFRs),VEGFR1, VEGR2, VEGFR3 and fibroblast growth factor receptors (FGFRs), FGFR1, FGFR2, FGFR3, FGFR4, and other receptor tyrosine kinases, PDGFR-alpha, KIT, RET. L envatinib have been approved for thyroid cancer, hepatocellular carcinoma, thymic caner and renal cell carcinoma (in combination with Everolimus or pembrolizumab. L envatinib is also approved for endometrium cancer in combination with pembrolIZumab, the anti- PD-1 antibody from Merck and France determine the safety and the recommended phase 2 dose (RP2D) and also to see the pharmacokinetics and efficacy of E7386 + Lenvatinib. Enrolment of each cohort of hepatic, colon, endometrial cancers are ongoing.

Eisai Co., Ltd. provided consolidated earnings guidance for the full year ending March 31, 2026. For the full year, the company expected net sales of JPY 790,000 million, operating profit of JPY 54,500 million, profit for the year of JPY 43,500 million, profit attributable to owners of parent of JPY 41,500 million and earnings per share attributable to owners of the parent of JPY 147.20.

Eisai Co., Ltd. announced dividend for year end of fiscal year ended March 31, 2025. For the year, the company announced a dividend of JPY 80.00 per share against JPY 80.00 per share a year ago. Expected date of dividend payment commencement: May 30, 2025. The company provided dividend guidance for second quarter end and year end of fiscal year ended March 31, 2026. For the second quarter end, the company expects to pay a dividend of JPY 80.00 per share against JPY 80.00 per share a year ago. For the year end of fiscal year ended March 31, 2026, the company expects to pay a dividend of JPY 80.00 per share against JPY 80.00 per share a year ago.

At the Board of Directors meeting held on May 15, 2025, Eisai Co., Ltd. resolved to propose a partial amendment to the Articles of Incorporation at the 113th Ordinary General Meeting of Shareholders to be held on June 18, 2025. This change is intended to clarify the management responsibilities of corporate officers in a given fiscal year by aligning their term of office with the fiscal year, setting the term to end on the final day of the fiscal year that concludes within one year of their election.

Eisai Co., Ltd., Annual General Meeting, Jun 18, 2025, 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 113th Fiscal Year (from April 1, 2024, to March 31, 2025); to consider contents of the financial statements for the 113th Fiscal Year (from April 1, 2024, to March 31, 2025); to consider Partial Amendment of the Articles of Incorporation; and to consider Appointment of 11 Directors.

Eisai Co., Ltd. (TSE:4523) proposed to acquire EcoNaviSta, Inc. (TSE:5585) from a group of shareholders for ¥17 billion on March 14, 2025. A cash consideration of ¥4.16 million valued at ¥1246 per share , of ¥3.39 million valued at ¥1823 per share , of ¥12.52 million valued at ¥1840 per share , of ¥126.86 million valued at ¥2115 per share and of ¥15 billion valued at ¥2190 per share will be paid by Eisai Co., Ltd. As part of consideration, ¥4.16 million is paid towards Fifth Series Share Acquisition Rights rights, ¥3.39 million is paid towards Fourth Series Share Acquisition Rights rights, ¥126.86 million is paid towards Second Series Share Acquisition Rights rights, ¥12.52 million is paid towards Third Series Share Acquisition Rights rights and ¥15 billion is paid towards common equity of EcoNaviSta, Inc. The transaction is subject to minimum tender. Nomura Securities Co., Ltd. acted as financial and TMI Associates acted as legal advisor to Eisai Co., Ltd. whereas Trustees Advisory K.K. acted as financial and City-Yuwa Partners acted as legal advisor to EcoNaviSta, Inc. Eisai Co., Ltd. (TSE:4523) completed the acquisition of EcoNaviSta, Inc. (TSE:5585) from a group of shareholders on May 7, 2025.

BioArctic AB's (publ) announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) have validated and will now evaluate a proposed Marketing Authorisation Variation for monthly lecanemab dosing in the United Kingdom. Maintenance dosing is an important step forward in providing flexibility to eligible patients and healthcare professionals. Leqembi is already approved in the UK for intravenous (IV) treatment every two weeks. The proposed intravenous maintenance dosing variation application offers the possibility to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult patients with early Alzheimer's disease in the UK after the initial 18 months of treatment of the currently approved dosing regimen. The submission is part of Eisai's ongoing commitment to addressing the unmet needs of people living with Alzheimer's disease, healthcare systems and wider society. The MHRA will evaluate the application and decide whether to approve or reject the proposal. Alzheimer's disease is a chronic disease which progresses in stages and increases in severity over time. Alzheimer's disease is the leading cause of death in the UK3, with early Alzheimer's disease usually being the first stage of the disease where symptoms become noticeable, such as forget recent events or conversations. As Alzheimer's disease progresses, everyday activities, hobbies and social engagements become more challenging, and independence is lost.

BioArctic AB's (publ) partner Eisai announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) have validated and will now evaluate a proposed Marketing Authorisation Variation for monthly lecanemab dosing in the United Kingdom. Maintenance dosing is an important step forward in providing flexibility to eligible patients and healthcare professionals. Leqembi is already approved in the UK for intravenous (IV) treatment every two weeks. The proposed intravenous maintenance dosing variation application offers the possibility to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult patients with early Alzheimer's disease in the UK after the initial 18 months of treatment of the currently approved dosing regimen. The submission is part of Eisai's ongoing commitment to addressing the unmet needs of people living with Alzheimer's disease, healthcare systems and wider society. The MHRA will evaluate the application and decide whether to approve or reject the proposal. Alzheimer's disease is a chronic disease which progresses in stages and increases in severity over time. Alzheimer's disease is the leading cause of death in the UK, with early Alzheimer's disease usually being the first stage of the disease where symptoms become noticeable, such as forget recent events or conversations. As Alzheimer's disease progresses, everyday activities, hobbies and social engagements become more challenging, and independence is lost. Leqembi is approved in the US, Japan, EU, China, United Kingdom and other markets. Lecanemab is approved in the U.S., Japan,EU, China, United Kingdom, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Lecanemab's approvals in these countries were primarily 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. For UK prescribing information, see Lecanemab United Kingdom Summary of Product Characteristics. Available at: >: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions. In January 2025, the supplemental Biologics License Application (sBLA) for intravenous (IV) maintenance dosing of the treatment was approved in the U.S. After an 18 months initiation phase with once every two weeks of dosing, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks or continuing 10 mg/kg once every two weeks may be considered. Additionally, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for the Leqembi subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date for August 31, 2025.

Alzheimer's Disease and Related Disorders Association, Inc., 2025 Alzheimer’s Association International Conference, Jul 27, 2025 through Jul 31, 2025. Venue: Toronto, Ontario, Canada.

Eisai Co., Ltd., 2025 Earnings Call, May 15, 2025

The European Commission has communicated that it has granted BioArctic AB's (publ) partner Eisai's application for Marketing Authorization of Leqembi (lecanemab) in the European Union (EU). This is the first therapy targeting an underlying cause of Alzheimer's disease (AD) to be granted an MA in the EU. In the EU, Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes with confirmed amyloid pathology. Leqembi's Market Authorization applies to all 27 EU Member States as well as Iceland, Liechtenstein and Norway. Leqembi is already approved in the US, Japan, China, Great Britain and in other markets.

Citius Oncology Inc. announced on March 28, 2025, Citius Oncology and Eisai Co., Ltd. entered into a letter agreement that amended the License Agreement to provide for a payment schedule to Eisai. Citius Oncology has agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $2,535,317.77 and thereafter on the 15th of each of the next four months to pay Eisai $2,350,000 and make a final payment of $2,197,892.07 to Eisai on or before December 15, 2025, in each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at the rate of 2% per annum. The parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to the failure of Citius Oncology to pay the milestone payment or the other incurred costs under the License Agreement except for any claims arising out of a breach of the letter agreement. All other terms of the License Agreement remain in full force and effect.

BioArctic AB (publ) announced that the company and partner Eisai will present data on real-world use of lecanemab at the 2025 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™?), to be held in Vienna, Austria, and virtually April 1-5. In total, lecanemab will be featured in six presentations and exidavnemab in one presentation. Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai. The anti-amyloid beta (Ab) protofibril 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. At AD/PD, Johanna Falting, BioArctic's Chief R&D Officer, will hold one oral presentation on exidavnemab, the company's proprietary drug candidate aimed at treating synucleinopathies. BioArctic will also present one poster related to lecanemab in Alzheimer's disease. In addition to BioArctic's presentations, Eisai will present four oral presentations and one poster presentation on lecanemab. These presentations will include the latest findings from real-world clinical evidence of lecanemab in the United States, efficacy and safety outcomes in apolipoprotein E e4 (ApoEe4) heterozygous carriers and non-carriers in the Phase 3 Clarity AD clinical study, and a subgroup analysis of Clarity AD open label extension study in the Asian region. Eisai will sponsor two symposiums on Alzheimer's Disease. Bridging the Gap in Alzheimer's Disease: From Pathophysiology to Treatment Strategy featuring three leading global experts in the field of Alzheimer's Disease, Dr. Dennis J. Selkoe (chair), Dr. Michael Heneka, and Dr. Miia Kivipelto. Presentations by BioArctic and EisAI. Bridging the gap in Alzheimer's disease treatment: From pathophysiology to treatment strategy, Dennis J. Selkoe, Michael Heneka, Miia Kivipelto, Industry Symposium 12, April 4, 13:50, - 15:50, Transforming Outcomes in Early AD: A Focus on Intervention and Management., Multidisciplinary coordination for early Alzheimer's disease: Insights from the first treatment centres. This release discusses investigational uses of an investigational use of an investigational use of lecanemab.

Eisai Co., Ltd., Board Meeting, Mar 14, 2025. Agenda: To consider to acquire the common shares and the share acquisition rights of EconaviSta Inc. through a tender offer pursuant to the provisions of the Financial Instruments and Exchange Act.

BioArctic AB's (publ) partner Eisai announced that the Therapeutic Goods Administration (TGA) of Australia has declined the approval of lecanemab (generic name) as a treatment for early Alzheimer's disease (AD) (mild cognitive impairment due to AD and mild AD dementia). Eisai remains committed to ensuring eligible Australians with early Alzheimer's disease can access lecanemab and is exploring options to achieve this, including potentially seeking review by the Administrative Review Tribunal. In October 2024, the TGA made the decision not to register lecanemab in Australia for the treatment of patients with early AD. In December 2024, Eisai requested reconsideration of the decision, proposing to the TGA the same apolipoprotein E4 (ApoE4) noncarrier and heterozygote indication that was agreed by the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA). In the course of the reconsideration of the initial decision, the TGA proposed an alternative narrow therapeutic indication only for ApoE4 noncarriers as an increasing number of ApoE4 alleles is a potential risk factor for ARIA. They did not agree that safety has been established for ApoE4 heterozygotes. Eisai proposed alternative indications, one of which was to maintain the ApoE4 noncarrier and heterozygote indication, but with heterozygotes treated in specialist centers and supervised by physicians with expertise in treatment of AD and monitoring for ARIA; however, the TGA rejected Eisai's proposal.

Eisai Co., Ltd., Board Meeting, Mar 07, 2025. Agenda: To consider appointment of new representative corporate officer; to consider change in representative corporate officer; and to transact such other business related issues.

Eisai Co., Ltd. announced that they will report fiscal year 2025 results at 12:30 PM, Tokyo Standard Time on May 15, 2025

Eisai Co., Ltd. announced that they will report Q1, 2026 results on Aug 05, 2025

Eisai Co., Ltd. Presents at World ADC London 2025, Mar-03-2025 . Venue: London, United Kingdom. Speakers: Hiroyuki Kato, Director, Shuntaro Tsukamoto, Scientist.

BioArctic AB’s (publ) partner Eisai announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two additional questions. These questions will now be discussed at the CHMP meeting in February 2025, before the Commission can take a final decision on the Marketing Authorization Application for lecanemab as treatment for early Alzheimer’s disease in the European Union. In November 2024, a positive opinion was received from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of lecanemab. As part of its decision-making process, the European Commission (EC) has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. These will be discussed at the CHMP meeting in February 2025. The safety profile of lecanemab reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified. Eisai believes that the existing information is clear and sufficient, allowing the EC’s requests to be addressed and evaluated by the CHMP. Eisai will continue to work closely with the authorities toward approval in the EU. Eisai will continue to make every effort to deliver lecanemab to patients with early AD in EU countries as soon as possible. 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 Lannfelt 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 Lecanemab for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and currently the two companies are preparing for a joint commercialization in the region.

Hanson Wade Limited, World ADC London 2025, Mar 03, 2025 through Mar 06, 2025. Venue: London, United Kingdom.

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. 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) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301) and its LTE study. Modeling simulations predict that transitioning to once every four weeks maintenance dosing after 18 months of once every two weeks treatment will maintain clinical and biomarker benefits of therapy. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal. Only LEQEMBI works to fight AD in two ways: continuously clearing protofibrils and rapidly clearing plaque. This is important because with continuous administration, LEQEMBI clears highly toxic protofibrils which can continue to cause neuronal injury even after the amyloid-beta (Aß) plaque has been cleared from the brain. Importance of Ongoing Treatment: Data from the off-treatment period between the Study 201 (Phase 2) core study and LTE showed that discontinuation of treatment is associated with reaccumulation of amyloid PET and plasma and CSF biomarkers, and reversion to placebo rate of clinical decline. For maintenance treatment, once every four weeks dosing regimen may be easier than once every two weeks dosing for patients and care partners to continue treatment for early AD. Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer. In the Clarity AD core study (18 months), the mean change from baseline between the once every two weeks lecanemab treated group and the placebo group was -0.45 (P<0.0001) on the primary endpoint of the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale. Over three years of treatment across the Clarity AD core study and LTE, LEQEMBI reduced cognitive decline on the CDR-SB by -0.95 relative to a matched natural history cohort, showing clinically meaningful benefit for early AD patients. A change from 0.5 to 1 on the CDR score domains of Memory, Community Affairs and Home/Hobbies is the difference between slight impairment and loss of independence, such as people's ability to be left alone, remember recent events, participate in daily activities, complete household chores, function independently and engage in hobbies and intellectual interests.

BioArctic AB (publ) announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's Supplemental Biologics License Application (sBLA) for Leqembi as a once every four weeks intravenous (IV) maintenance dosing. Leqembi is indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the U.S. (early Alzheimer's disease). This approval means that patients who have completed the biweekly initiation phase of 18 months have the option to transition to a once every four weeks 10 mg/kg dosing regimen.

Merck, known as MSD outside of the United States and Canada, and Eisai announced results from the Phase 3 LEAP-015 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 chemotherapy (KEYTRUDA plus LENVIMA-based regimen), for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma. At an interim analysis, the KEYTRUDA plus LENVIMA-based regimen demonstrated a statistically significant improvement in progression-free survival (PFS), one of the study’s dual primary endpoints, and objective response rate (ORR), a key secondary endpoint, compared to standard of care chemotherapy. The study continued, and at the final analysis, it did not meet its other primary endpoint of overall survival (OS). The safety profile of the KEYTRUDA plus LENVIMA-based regimen was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing, and Merck and Eisai will present these results at an upcoming medical meeting. KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Lenvatinib is marketed as KISPLYX for advanced RCC in the EU. Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in hepatocellular carcinoma and esophageal cancer across multiple clinical trials. In gastric cancer, KEYTRUDA is approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma based on OS and other data from the Phase 3 KEYNOTE-859 trial. KEYTRUDA is also approved in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, whose tumors express PD-L1 (Combined Positive Score [CPS] =1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response data from the Phase 3 KEYNOTE-811 trial. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In esophageal cancer, KEYTRUDA is approved in combination with platinum- and fluoropyrimidine-based chemotherapy for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation. This approval is based on OS and other data from the Phase 3 KEYNOTE-590 trial. Results from the LEAP-015 trial do not affect the current approved indications for KEYTRUDA plus LENVIMA or other ongoing trials from the LEAP clinical program.

Eisai Co., Ltd. Presents at ADD Pharmacokinetics & Clinical Pharmacology Summit, Oct-08-2024 09:00 AM. Venue: Hilton Boston Back Bay, 40 Dalton Street, Boston, Massachusetts, United States. Speakers: Earl Albone, Executive Director, Biochemistry & Bioanalytical Development, & Operations.

Eisai Co., Ltd. - Analyst/Investor Day

H.A.C. Pharma SAS acquired the European and UK rights to TARGRETIN® (bexarotene) from Eisai Co., Ltd. (TSE:4523) on January 6, 2025. Dentons Europe, Association d'Avocats à Responsabilité Professionnelle Individuelle acted as legal advisor for H.A.C. Pharma SAS. The team was led by Julien Le Guyader (Partner and Co-Head of the Paris Life Sciences team), Guillaume Kessler (Partner, Corporate and M&A), and Loïc Lemercier (Partner, Intellectual Property). H.A.C. Pharma SAS completed the acquisition of the European and UK rights to TARGRETIN® (bexarotene) from Eisai Co., Ltd. (TSE:4523) on January 6, 2025.

Eisai Co., Ltd. Presents at BIO Partnering @JPM Week, Jan-13-2025 . Venue: San Francisco Marriott Marquis, San Francisco, California, United States.

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. 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). A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI). The injection process is expected to take, on average, 15 seconds. As part of the SC-AI 360 mg weekly maintenance regimen, patients who have completed the biweekly intravenous (IV) initiation phase, exact period under discussion with the FDA, would receive weekly doses that are expected to maintain the clinical and biomarker benefits. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque deposition. Only LEQEMBI works to fight AD in two ways by continuously clearing protofibrils and rapidly clearing plaque. With continuous administration, LEQEMBI clears highly toxic protofibrils* which can continue to cause neuronal injury even after amyloid-beta (Aß) plaque has been cleared from the brain. Long-term three-year LEQEMBI data presented at the Alzheimer's Association International Conference (AAIC) 2024 suggest that early and continuing treatment may prolong the benefit of therapy even after plaque is cleared from the brain. The SC-AI is expected to be simple and easy for patients and their care partners to use, and may reduce the need for hospital or infusion site visits and nursing care for IV administration, which will make it easier to continue maintenance administration and may contribute to further simplifying the treatment pathway for AD. LEQEMBI is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico, and Macau. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. Eisai has submitted applications for approval of lecanemab in 17 countries and regions. The US FDA accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly LEQEMBI IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025. 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 believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of 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. expected to report Fiscal Year 2025 results on May 13, 2025. This event was calculated by S&P Global (Created on January 9, 2025).

Hanson Wade Limited, ADD Pharmacokinetics & Clinical Pharmacology Summit, Oct 08, 2024 through Oct 10, 2024. Venue: Hilton Boston Back Bay, 40 Dalton Street, Boston, Massachusetts, United States.

Eisai Co., Ltd., Q3 2025 Earnings Call, Feb 07, 2025

Fujirebio Holdings, Inc. and Eisai Co., Ltd. announced that they have entered into a memorandum of understanding for the joint research and social implementation of novel blood-based biomarkers in the field of neurodegenerative diseases. Fujirebio and Eisai have been conducting joint research on cerebrospinal fluid biomarkers related to Alzheimer’s disease (AD). The two companies have agreed to move forward with their partnership based on the shared understanding that the development and commercialization of diagnostic methods for neurodegenerative diseases can be accelerated by integrating the long-standing respective expertise of Fujirebio, which has experience in the research and development of test reagents in the neurodegenerative disease field, and Eisai, which has been engaged in the research and development of therapeutics in the field of dementia. The partners plan to explore a wide range of possibilities for the collaboration, including the clinical implementation of diagnostic reagents for plasma phosphorylated tau 217 protein (p-Tau217), the research and development of simple diagnostic methods using novel blood-based biomarkers and the development and commercialization of in vitro diagnostics. Through this non-exclusive partnership, Fujirebio and Eisai will establish diagnostic technologies for various neurodegenerative diseases with high unmet medical needs, and accelerate the expansion of these technologies globally to establish an environment where appropriate treatments can be selected and provided, thereby contributing to improvement in the diagnosis and treatment of neurodegenerative diseases.

Eisai Co., Ltd. and Biogen Inc. announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Ab) monoclonal antibody "LEQEMBI®?" (lecanemab) for the treatment of early Alzheimer's disease (AD). Lecanemab is approved and being marketed in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates and Great Britain for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Imairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The treatment'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 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. Lecanemab is under regulatory review in 16 countries and regions, including the European Union. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. 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. 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 claims; and third party collaboration risks, results of operations; and third party collaboration risks.

Eisai Co., Ltd. and Biogen Inc. announced that the humanized anti-soluble aggregated amyloid-beta (Aß) monoclonal antibody "LEQEMBI®" has been launched in South Korea. LEQEMBI received the Ministry of Food and Drug Safety (MFDS) approval in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD). LEQEMBI selectively binds to soluble Aß aggregates (protofibrils*), as well as insoluble Aß aggregates (fibrils) which are a major component of Aß plaques in AD, thereby reducing both Aß protofibrils and Aß plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. It is estimated there were approximately 900,000 dementia patients in South Korea in 2021, with one in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). It is reported that Alzheimer's dementia patients account for about 70% of all dementia patients.2 The average annual nursing care/medical costs per dementia patient is estimated to be 21.1 million South Korean Won (KRW), while the cost for patients with severe dementia reaches 33.1 million KRW. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In South Korea, Eisai Korea Inc. will distribute the product and conduct information provision activities. Eisai Korea Inc. has been a pioneer in the field of dementia for many years, focusing on activities such as raising disease awareness. In recent years, Eisai Korea Inc. has been working with various stakeholders, including healthcare professionals, academic societies, patient groups, care centers, health checkup companies, and diagnostic companies, to create a dementia ecosystem that promotes AD awareness and early diagnosis/treatment. Eisai Korea Inc. will first launch this drug in the private market, including the establishment of a Patient Assistance Program, to deliver lecanemab to patients awaiting the treatment, aiming to make an impact not only on patients but also on their caregiving families and South Korean society. Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aß, having a primary role in the cognitive decline associated with this progressive, debilitating condition.3 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. Notes to Editors: About Lecanemab: Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aß). Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates and Great Britain 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 treatment'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 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. Lecanemab is marketed in the U.S., Japan, China, Great Britain and others, and is under regulatory review in 17 countries and regions, including the European Union. In November 2024, the treatment received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval. 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. About the Collaboration between Eisai and Biogen for 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. About the Collaboration between Eisai and BioArctic for AD: 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 back-up was signed in May 2015.

BioArctic AB's (publ) partner Eisai announced that Leqembi (generic name: lecanemab) has been launched in South Korea. Leqembi received approval in South Korea in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD). Eisai estimates there were approximately 900,000 dementia patients in South Korea in 2021, with one in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). It is reported that Alzheimer's dementia patients account for about 70% of all dementia patients. In South Korea, Eisai will first launch Leqembi in the private market. Leqembi selectively binds to soluble amyloid-beta (Aß) aggregates (protofibrils[2]), as well as insoluble Aß aggregates (fibrils) which are a major component of Aß plaques in AD, thereby reducing both Aß protofibrils and Aß plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. 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 Lannfelt 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 Lecanemab for Alzheimer's disease. BioArctic has the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Eisai Co., Ltd. and Biogen Inc. announced a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aß) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and 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. Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024. In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion. Lecanemab selectively binds to soluble Aß aggregates (protofibrils), as well as insoluble Aß aggregates (fibrils) which are a major component of Aß plaques in AD, thereby reducing both Aß protofibrils and Aß plaques in the brain. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic AB (publ) announced that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai's marketing authorization application (MAA) for lecanemab as treatment of Alzheimer's disease. The recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers.  The CHMP recommendation for the European Commission to approve lecanemab follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A decision from the European Commission is expected within 67 days. The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) or are non-carriers of the Apolipoprotein E e4 (ApoE e4) gene. Lecanemab is already approved in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and the Great Britain. Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the rights to commercialize lecanemab in the Nordic region. Currently, BioArctic and Eisai are preparing for joint commercialization in these countries, pending approval from the European Commission.

Eisai Co., Ltd., ¥ 80.0, Cash Dividend, Mar-28-2025

Eisai Co., Ltd. and Biogen Inc. announced that the latest findings for lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aß) protofibril antibody for the treatment of early Alzheimer's disease (AD), were presented at the Clinical Trials for Alzheimer's Disease Conference (CTAD), held in Madrid, Spain, and virtually. Benefits of Continued Treatment with Lecanemab for People with Early AD: In July 2024 at the Alzheimer's Association International Conference (AAIC) 2024, results from the open-label long-term extension study (OLE) following the core study of the lecanemab Phase 3 Clarity AD study were presented, showing that the mean change from baseline in CDR-SB (global cognitive and functional scale) in the lecanemab treated group relative to the placebo group was -0.45 at 18 months, and at 36 months, this expanded to -0.95 compared to a prespecified natural history cohort of AD. There was a 30% reduction in the relative risk of progressing to the next disease stage In addition, the tau PET substudy of the lecanemab Phase 3 Clarity AD clinical study showed that with three (3) years of continuous treatment with lecanemab, 59% of patients with no or low tau accumulation in the brain (no tau/low tau) at baseline showed improvement or no decline, and 51% showed improvement from baseline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale. Clarity AD data presented at CTAD expand on these initial results to include additional measurements resulting from three (3) years of continuous lecanemab treatment in patients with low levels of amyloid accumulation in the brain at baseline (less than 60 Centiloids: low amyloid). These data show that 46% of patients improved or had no decline, and 33% showed improvement from baseline on the CDR-SB. On the ADAS-Cog14 measurement scale, 46% of patients showed improvement or no decline and 43% showed improvement. On the ADCS MCI-ADL, 51% of patients showed improvement or no decline and 48% showed improvement. These results from no tau/low tau population and low amyloid populations – suggest that earlier initiation of lecanemab treatment may have a positive impact on disease progression of early AD patients and may provide continued benefits to patients with early AD over the long term. No new safety findings were observed with continued lecanemab treatment over three (3) years. Most amyloid-related imaging abnormalities (ARIA) occurred in the first six (6) months of treatment. After the first six (6) months, ARIA rates were low and similar to ARIA rates on placebo during the placebo-controlled period. With regards to the incidence of ARIA by ApoEe4 status during the continuous treatment, the incidence was higher in ApoE4 homozygotes than in heterozygotes or non-carriers, but rates of new ARIA were decreased after the completion of the 18 months core study as treatment continued, regardless of ApoEe4 status. Correlation between Protofibrils and Biomarkers for Neurodegenerative Disease in the AD Brain: Dual-acting lecanemab is the only early AD treatment available to support neuronal function by clearing the highly toxic protofibrils that continue to cause neuronal injury and death even after plaques have been cleared from the brain. Protofibrils accumulate early in the AD brain and lead to nerve cell function loss, abnormal nerve processes, inflammation, and memory loss. In non-clinical studies, antibodies against protofibrils prevented protofibril-mediated neuronal dysfunction and memory loss. Accurately quantifying the amount of protofibrils in human cerebrospinal fluid (CSF) has been challenging due to their low concentration. As such, a new measurement method was developed by researchers at Eisai to accurately quantify protofibrils in CSF. Utilizing this new method of measurement, the amount of protofibrils in AD CSF correlated more strongly with neurodegenerative disease biomarkers (CSF total tau and neurogranin) than with CSF Aß42, a biomarker associated with Aß plaques accumulation, indicating that protofibrils are closely related to synaptic dysfunction. Furthermore, it was observed that protofibrils, unlike plaques, are diffusible. These results suggest that protofibrils induce synaptic dysfunction, playing an important role in neurodegeneration in AD brains. Progress in the AHEAD 3-45 Study: Improving Screening Eligibility Using Blood Biomarkers and Completing Patient Enrollment: AHEAD 3-45 is a Phase 3 clinical study for individuals with preclinical AD, meaning they are clinically unimpaired but have intermediate or elevated levels of amyloid in their brains. In the study, blood tests, cognitive function tests (PACC-5), amyloid PET, MRI, and tau PET were used for screening. Based on the amount of Aß accumulation in the brain as determined by amyloid PET, subjects were assigned to two (2) trials with different dose settings: the A3 trial, for those with borderline Aß levels in the brain, and the A45 trial, for those with positive Aß levels in the brain. Screening with blood biomarker tests was important to improve eligibility for amyloid PET testing in subjects without cognitive impairment. Using plasma Aß42/40 ratio and p-tau217/tau217 ratio in the initial screening reduced screening failure on amyloid PET from more than 70% to less than 30%. In particular, plasma p-tau217 was shown to correlate with amyloid PET, supporting its role as a useful blood biomarker to identify elevated amyloid in the brain. Enrollment for the AHEAD 3-45 study was completed in October 2024.

BioArctic AB's partner Eisai announced that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. 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 BLA is based on data from the Clarity AD open-label extension (OLE) study and modeling of observed data. If the application is approved by the FDA, the Leqembi autoinjector could be used to administer Leqembi at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils[1][2] which can continue to cause neuronal injury even after the amyloid-beta (Aß) plaque has been cleared from the brain. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. AD is an ongoing neurotoxic process that begins before and continues after plaque deposition. Data suggest that early and continuing treatment may prolong the benefit even after plaque is cleared from the brain. This SC autoinjector is expected to be easier for patients and their care partners to use and may reduce the need for hospital visits and nursing care compared to IV administration. In addition to potentially maintaining the clinical and biomarker benefits, subcutaneous maintenance dosing may be more convenient for patients and their care partners to continue the treatment.Leqembi is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union (EU). The US FDA accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly Leqembi IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025.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 Lars Lannfelt 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 lecanemab for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury even after the amyloid-beta (Aß) plaque has been cleared from the brain. AD is an ongoing neurotoxic process that begins before and continues after plaque deposition. Data suggest that early and continuing treatment may prolong the benefit of therapy even after plaque is cleared from the brain. This SC autoinjector is expected to be easier for patients and their care partners to use and may reduce the need for hospital or infusion site visits and nursing care compared to IV administration. In addition to potentially maintaining the clinical and biomarker benefits, subcutaneous maintenance dosing may be more convenient for patients and their care partners to continue the treatment. LEQEMBI is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union (EU). The US FDA accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly LEQEMBI IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025. 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. LEQEMBI [(lecanemab-irmb) 100 mg/mL injection for intravenous use] 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.

Eisai Co., Ltd. Presents at World Drug Safety Congress US, Oct-29-2024 11:10 AM. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States. Speakers: Mamiko Kasho.

Eisai Co., Ltd. Presents at 17th Clinical Trials on Alzheimer ’s Disease (CTAD) conference 2024, Oct-29-2024 through Nov-01-2024. Presentation Date(s): Nov-01-2024. Oct-29-2024. Oct-30-2024. Oct-31-2024.

Eisai Co., Ltd., Q2 2025 Earnings Call, Nov 08, 2024

Meeting to Exchange Opinions on Value Creation Report 2024 and ESG

Eisai Co., Ltd. Presents at 17th Annual Clinical Trials on Alzheimer’s Disease Conference (CTAD24), Oct-30-2024 01:45 PM. Venue: Madrid Marriott Auditorium Hotel and Conference Center, Madrid, Spain. Speakers: Jin Zhou.

From October 1, 2024 to October 3, 2024, the company has repurchased 165,300 shares, representing 0.06% for ¥901.4 million. With this, the company has completed the repurchase of 4,917,800 shares, representing 1.72% for ¥29,999.56 million under the buyback announced on May 15, 2024.

The company closed its plan on October 3, 2024.

Ctad Congress, Annual Alzheimer's conference - Clinical Trials in Alzheimer's Disease, Oct 29, 2024 through Nov 01, 2024. Venue: Spain.

From July 1, 2024 to September 30, 2024, the company has repurchased 3,470,300 shares, representing 1.22% for ¥20,627.64 million. With this, the company has completed the repurchase of 4,752,500 shares, representing 1.66% for ¥29,098.16 million under the buyback announced on May 15, 2024.

Eisai Co., Ltd. Presents at Safety Pharmacology Society (SPS) Annual Meeting, Sep-22-2024 . Venue: San Deiego, California, United States. Speakers: Daigo Homma, Takashi Yoshinaga, Yuki Seki.

Safety Pharmacology Society, Safety Pharmacology Society (SPS) Annual Meeting, Sep 22, 2024 through Sep 25, 2024. Venue: San Deiego, California, United States.

Merck and Eisai announced results from the first interim analysis of 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) compared to TACE alone for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC). These late-breaking data are being presented for the first time on September 14, 2024 during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #LBA3). After a median follow-up of 25.6 months (range, 12.6-43.5), KEYTRUDA plus LENVIMA in combination with TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.51-0.84]; p=0.0002) compared to TACE alone. Median PFS was 14.6 months (95% CI, 12.6-16.7) for the KEYTRUDA plus LENVIMA-based regimen versus 10.0 months (95% CI, 8.1-12.2) for TACE alone. At this analysis, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for the KEYTRUDA plus LENVIMA-based regimen versus TACE alone (HR=0.80 [95% CI, 0.57-1.11]; p=0.0867); the OS data are not mature and did not reach statistical significance at the time of this interim analysis. The trial is continuing, and follow-up of OS is ongoing. The safety profile of the KEYTRUDA plus LENVIMA-based regimen was consistent with that observed in previously reported studies evaluating the combination. Treatment was administered to 237 patients receiving the KEYTRUDA plus LENVIMA-based regimen and 241 patients receiving TACE alone. Treatment-related adverse events (TRAEs) occurred in 98.7% of patients receiving KEYTRUDA plus LENVIMA in combination with TACE versus 84.6% of patients receiving TACE alone and led to the discontinuation of both study drugs in 8.4% versus 1.2% of patients, respectively. Serious adverse events were observed in 33.3% of patients receiving KEYTRUDA plus LENVIMA in combination with TACE versus 12.4% of patients receiving TACE alone. Grade 3 or 4 TRAEs occurred in 71.3% of patients receiving KEYTRUDA plus LENVIMA in combination with TACE versus 31.1% for TACE alone, and TRAEs led to death in 1.7% (n=4) versus 0.4% (n=1) of patients, respectively. LENVIMA monotherapy is approved for the treatment of patients with unresectable HCC in more than 80 countries, including in the U.S., Europe, China and Japan. KEYTRUDA is approved as a monotherapy for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen in the U.S. and as a monotherapy for the treatment of patients with HCC who have been previously treated with sorafenib or oxaliplatin-containing chemotherapy in China. Study design and additional data from LEAP-012: LEAP-012 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04246177) evaluating KEYTRUDA plus LENVIMA in combination with TACE versus dual placebo plus TACE for the treatment of patients with unresectable, non-metastatic HCC. The primary endpoints are PFS as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) following a maximum of five target lesions and with a requirement that new intrahepatic lesions must meet LI-RADS 5 criteria and OS. Secondary endpoints include objective response rate, duration of response, disease control rate, and time to progression as assessed by BICR per RECIST v1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST), as well as PFS as assessed by BICR per mRECIST and safety. The study randomized 480 patients 1:1 to receive: KEYTRUDA (400 mg intravenously [IV] every six weeks [Q6W]) plus LENVIMA (12 mg [for participants with screening body weight =60 kg] or 8 mg [for participants with screening body weight <60 kg] orally once a day) in combination with TACE (conducted as a background procedure of chemotherapeutic and embolic agents injected via hepatic artery 2-4 weeks after start of study intervention, and after the first tumor assessment scan and =1 month after the first TACE); or IV placebo administered Q6W plus oral placebo administered once a day in combination with TACE. All study drugs were continued until protocol-specified discontinuation criteria. KEYTRUDA was administered for up to two years (approximately 18 doses). After completing two years of combination therapy, LENVIMA may have been administered as a single agent until protocol-specified discontinuation criteria were met.

Eisai announced the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2024, which is taking place virtually and in-person in Barcelona, Spain from September 13 to 17. First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA), Merck's anti-PD-1 therapy, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC) will be featured in an ESMO Presidential Symposium (NCT04246177; Presentation: #LBA3). Additionally, a Mini Oral presentation will feature real-world evidence for patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) treated with lenvatinib monotherapy in Europe and Canada (Presentation: #1926MO). Cancer Type Study/Compound Abstract Title Abstract Type & Details L envatinib Plus Pembrolizumab: Cancer with or without lenvatinib (len) plus pembrolizumib (pembro) for intermediate stage hepatocellular carcinoma ("HCC") (HCC): phase 3 LEAP-012 study* Presentation #LBA3 September 14, 2024.arcinoma lenvatinib plus pembrolizumumab (LEN + Pembro) in the ENGOT-en9/LEAP-001 study. Presentation #737P September 14, 2024. L envatinib (LEN + Pem Bro) in the ENGOT-EN9/LEAP-001 studies. L envatinib (S) in patients Poster Session (pts) with advanced or unresectablehepatocellular carcinoma (uHCC): an international, multicenter, phase 4 study (STELLAR) Presentation #964P September 16, 2024.