Corporate Events

Topline data from the Phase 2 study of KHK4951 in patients with nAMD

Kyowa Kirin Co., Ltd., Q2 2026 Earnings Call, Aug 03, 2026

Kyowa Kirin Co., Ltd. announced that the U.S. Food and Drug Administration has selected Kyowa Kirin’s Sanford manufacturing facility for the FDA PreCheck Pilot Program. Kyowa Kirin’s selection into the program enables the operational acceleration of the biologics manufacturing facility currently under construction in Sanford, North Carolina. By initiating structured, early-stage regulatory engagement during the facility's build phase, the PreCheck Pilot Program is designed to optimize current Good Manufacturing Practices compliance and validation, accelerate commercial production timelines, and strengthen supply chain resilience for rare disease patients. The Sanford facility, which broke ground in late 2024 and is on track to be operational by 2027, will serve as a core U.S. hub for manufacturing innovative biologic therapies, with a strong emphasis on next-generation antibodies for rare and orphan diseases. Complex biologics, such as those developed for rare diseases, often require highly specialized, low-volume, high-complexity manufacturing processes that can be vulnerable to regulatory bottlenecks. The FDA PreCheck Program addresses these challenges by replacing sequential reviews with a proactive, two-phase collaborative framework: Phase 1 (Facility Readiness Phase): Kyowa Kirin will utilize a facility-specific Type V Drug Master File to receive real-time technical feedback from the FDA regarding equipment qualification and Pharmaceutical Quality System design. This eliminates the risk of post-construction compliance gaps and costly retrofits. Phase 2 (Application Submission Phase): The partnership shifts to structured pre-submission engagements that streamline Chemistry, Manufacturing, and Controls reviews, significantly shortening the timeline between drug application and approval.

Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced encouraging long-term results from the Phase 1/2 KOMET-007 single-arm trial (NCT05735184) evaluating ziftomenib in combination with intensive chemotherapy, 7+3, in newly diagnosed NPM1-m or KMT2A-r AML. These results will be presented at the European Hematology Association 2026 Congress. These data compare favorably to historical standard-of-care data with 7+3 alone: NPM1-m Patients KOMET-007 1 Historical 7+3 Benchmark CR Age = 65 years Age > 65 years 91% (31/34) 100% (15/15) 88%2 56%2 CRc 96% 56-89%2,3,4 CR MRD- (bone marrow) 56% 44%5 12-month OS rate 94% ~ 70-80% in younger fit patients3,4,5 ~ 45-55% in patients > 65 years old2,6 1KOMET-007 (N=49) at 600 mg ziftomenib; MRD neg < 10-4; 2Lachowiez et al., Blood Adv. 2020; 4(7): 1311–1320; 3Herna´ndez-Sa´nchez et al., Leukemia. 2026; 40(2): 418-428; 4Othus et al. Leukemia. 2019; 33(2):371-378; 5Othman et al., Blood. 2024; 144(7):714-728, including Supplemental Material; 6Recher et al., Leukemia. 2022; 36(4): 913-922. KOMZIFTITM (ziftomenib) is approved by the U.S. Food and Drug Administration (FDA) as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The use of ziftomenib in combination with 7+3 is investigational and has not been approved by any health authority. As of the data cut-off on April 10, 2026: High remission rates across both molecular subtypes •96% CRc and 98% ORR in NPM1-m AML, 90% CRc and 92% ORR in KMT2A-r AML. Deep molecular responses, including marrow central MRD assessment •Local CRc MRD-negativity rates were 85% in NPM1-m AML and 82% in KMT2A-r AML •In NPM1-m AML, marrow central MRD negativity (10-4, NGS) among CRc responders was 79% (31/39) at the <0.1% threshold and 56% (22/39) at the <0.01% threshold, with all CRc responders who achieved central MRD negativity doing so by Cycle 2. Durable responses and encouraging durability with extended follow-up •After median follow-up of nearly 18 months (range 1.0-23.5) in NPM1-m AML and 11.0 months (range 0.9-21.9) in KMT2A-r AML, median duration of complete response was not reached for the NPM1-m AML cohort and was 12 months for the KMT2A-r AML cohort •Median OS was not reached, with median follow-up of 17.6 months in NPM1-m and 11.0 in KMT2A-r, respectively •NPM1-m: 94% OS rate at 12 months (range 1.0-23.5) •KMT2A-r: 71% OS rate at 12 months (range 0.9-21.9) •The majority of patients remained alive and continued on study at time of data cut-off: •NPM1-m: 90% (44/49) •KMT2A-r: 62% (31/50). Consistent and manageable safety profile •Ziftomenib 600 mg once-daily plus 7+3 was generally well tolerated, with no new or unexpected safety signals observed with longer follow-up •Low rates of ziftomenib-related cytopenias and minimal additive myelosuppression were observed with this combination •Ziftomenib 600 mg once-daily did not delay neutrophil or platelet count recovery •No Grade 4 differentiation syndrome or QTc prolongation events were reported •Four patients (4%) experienced Grade 3 differentiation syndrome; all cases successfully resolved with protocol-specified mitigation and three continued on ziftomenib treatment •Three patients (3%) experienced Grade 3 investigator-assessed QTc prolongation (all three on azole antifungals, fluoroquinolones, or other medications at time of assessment; one with ongoing hypokalemia and hypomagnesemia); none were assessed as ziftomenib-related and all QTc events successfully resolved with all patients continuing on ziftomenib treatment •60-day mortality rate of 2% (1/49) in NPM1-m patients. The companies plan to publish these data in a peer-reviewed publication in the second half of 2026.

Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden. The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML. As of the abstract data cut-off on January 16, 2026: High response rates across both molecular subtypes o Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML; Deep molecular responses o Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML; Encouraging durability with extended follow-up o Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r) o Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r); Consistent and manageable safety profile o Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment; Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation.

Kyowa Kirin Co., Ltd. announced that it plans to create a research hub to further improve its capabilities in drug discovery. The plan is to integrate two existing sites, the Fuji Site (Fuji Research Park; CMC R&D Center) and Tokyo Research Park, into a new integrated research hub at Yokohama Business Park. Specific conditions and the implementation schedule will be determined through further reviews with relevant stakeholders. Following the potential launch of the new research hub, Kyowa Kirin is considering the closure of both the Fuji Site and Tokyo Research Park. Kyowa Kirin is advancing initiatives to further enhance the way its research and development activities are conducted, guided by its mission to deliver life-changing value to patients. The company aims to create a research environment in which Drug Discovery, Translational Research, and Chemistry, Manufacturing and Controls engage in ongoing, day-to-day discussions from the early stages of research. By strengthening collaboration across these functions, Kyowa Kirin seeks to enable research design and faster decision-making with downstream development and manufacturing in mind. The new integrated research hub represents one of multiple measures Kyowa Kirin is pursuing to enhance its drug discovery capabilities, building on the important role both research parks have played in Kyowa Kirin’s history of research and drug discovery. The new hub will build on the strengths, expertise, and research culture developed at these sites, while exploring a research framework suited to the next era. This effort is a part of the company’s growth story Vision 2030 and Beyond. Location is Yokohama Business Park. Use is drug discovery research, Translational Research, CMC research and related activities. Key features include integrated hub combining Drug Discovery, Translational Research and CMC, jointly designed by Kyowa Kirin and the facility owner, approximately 15 minutes from Shin-Yokohama Station; urban location to enhance talent attraction and retention. Owner is Nomura Real Estate Development Co., Ltd.

Kyowa Kirin Co., Ltd. announced that they will report Q2, 2026 results at 9:00 AM, Tokyo Standard Time on Aug 03, 2026

Kyowa Kirin Co., Ltd. reported earnings results for the first quarter ended March 31, 2026. For the first quarter, the company reported sales was JPY 118,467 million compared to JPY 104,725 million a year ago. Net income was JPY 12,034 million compared to JPY 6,167 million a year ago. Basic earnings per share from continuing operations was JPY 22.99 compared to JPY 11.78 a year ago.

Kyowa Kirin Co., Ltd. and Kura Oncology, Inc. announced the first patient has been dosed in a Japanese Phase 2 registrational clinical trial (jRCT2031250550) studying ziftomenib, an oral menin inhibitor, for the treatment of relapsed or refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML). NPM1-m AML accounts for approximately 30% of AML patients. Following completion of this clinical trial, Kyowa Kirin plans to file for regulatory approval in Japan. Ziftomenib was approved by the U.S. Food and Drug Administration in November 2025 for the treatment of adult patients with R/R NPM1-m AML who have no satisfactory alternative treatment options, under the brand name KOMZIFTI. The trial initiated by Kyowa Kirin is a multicenter, single-arm, open-label Japanese Phase 2 clinical trial evaluating the efficacy and safety of ziftomenib in adult patients with R/R NPM1-m AML. As the primary endpoint, the trial will assess a composite complete remission rate consisting of complete remission (CR) and complete remission with partial hematologic recovery (CRh). Ziftomenib is in development in combination with standard-of-care and targeted therapies for the front-line treatment of AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to benefit a broad spectrum of patients earlier in their disease course. KOMZIFTI is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement. KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). In the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML with an NPM1 mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients. Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10?/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death. Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Adverse reactions that required dose interruption in = 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist. Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid. Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms. Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI. Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose. Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential.

Kyowa Kirin Co., Ltd. announced that they will report Q1, 2026 results on May 07, 2026

Kyowa Kirin Co., Ltd. Presents at 2026 Cell & Gene Meeting on the Mediterranean, Apr-28-2026 . Venue: Rome Cavalieri, Salone dei Cavalieri, Section 1, Rome, Italy.

Kyowa Kirin Co., Ltd., Q1 2026 Earnings Call, May 07, 2026

Kyowa Kirin Co., Ltd., ¥ 35.0, Cash Dividend, Jun-29-2026

Kyowa Kirin Co., Ltd. expected to report First-Half, 2026 results on July 31, 2026. This event was calculated by S&P Global (Created on April 2, 2026).

Kyowa Kirin Co., Ltd., Board Meeting, Mar 19, 2026. Agenda: To consider the Notice Regarding Disposal of Treasury Shares Used for Restricted Share-Based Remuneration and Performance-Linked Share-Based Remuneration.

Kyowa Kirin Co., Ltd. announced the discontinuation of all ongoing clinical trials for rocatinlimab, an investigational anti-OX40 monoclonal antibody being evaluated for potential indications in moderate-to-severe atopic dermatitis, prurigo nodularis, and moderate-to-severe asthma. This decision was informed by a recent planned safety update from the global rocatinlimab clinical program. Based on this update, Kyowa Kirin and Amgen have concluded that the potential risks may outweigh the benefits for the studied patient populations. This determination reflects the totality of emerging safety information, including previously reported safety risks. The most recent safety review conducted over the last several weeks identified emerging concerns of malignancies with possible viral or immune-related links. This included one new confirmed case and one suspected case of Kaposi’s sarcoma, in addition to the previously confirmed case, suggesting a potential mechanistic link to OX40 pathway modulation. While the overall number of malignancy cases across the program remains below expected background rates, the characteristics of these cases raise a plausible biological concern that cannot be excluded. Both companies are currently notifying clinical trial investigators and regulatory authorities. After trial participants complete required safety follow-up visits, all studies will be formally terminated. The companies will work together to conduct a comprehensive analysis of the full dataset and are committed to providing further updates once data assessments are complete.

IR EVENT

Kyowa Kirin Co., Ltd. Presents at BIO Investment & Growth Summit, Mar-02-2026 . Venue: Eden Roc Miami Beach, Miami Beach, Florida, United States.

Cowellnex Co., Ltd., Kyowa Kirin Co., Ltd. and and Metagen, Inc. announced to begin joint research in February 2026 to develop new test items based on gut microbiota data from Japanese individuals, as well as an algorithm (mechanism) that proposes foods suited to each person based on these test items. This research will leverage Cowellnex’s independently acquired, high-precision gut microbiota data obtained through shotgun metagenomic analysis*1—one of Japan’s most detailed gut microbiota tests—accumulated over approximately three years through its “MicroBio Me”*2 service. The companies aim to commercialize and introduce the resulting new testing services to the market in the future. Gut microbiota has been gaining attention in recent years from a health maintenance perspective. However, because the composition (types and ratios) of gut bacteria varies greatly among individuals, dietary approaches also differ. As a result, indicators that show the desired state of gut microbiota for each person and concrete action guidelines are not yet sufficiently developed. The commonly used 16S rRNA gene analysis*3 helps grasp broad bacterial classifications but provides limited information compared with shotgun metagenomic analysis. Furthermore, methods academically established for test items or food recommendations based on gut microbiota data specifically for Japanese individuals currently do not exist. Against this backdrop, expectations are increasing for more accurate gut microbiota testing and for testing items and personalized food recommendations based on such data. In the MicroBio Me business operated by Cowellnex, the company has accumulated highly precise data over approximately three years using shotgun metagenomic analysis, one of the most detailed gut microbiota tests available in Japan. Leveraging these data, Cowellnex will create new test parameters that take into account the characteristics of the gut environment of Japanese people, and will develop an algorithm (mechanism) that proposes foods based on those parameters. In this joint research, Cowellnex will be responsible for providing data, formulating hypotheses for test parameters and food recommendations, and conducting acceptability verification. Metagen will be responsible for conducting metabolic pathway analysis based on its expertise in gut environment research and bioinformatics, as well as for developing the algorithm (mechanism) for food recommendations. Through this joint research, it will become possible not only to identify which gut bacteria are present but also to predict the overall capability of the gut environment—including interactions among gut bacteria—to produce beneficial metabolites. A series of consecutive chemical reactions along metabolic pathways carried out by gut bacteria. Through these processes, dietary fiber is broken down and various metabolites are produced. Cowellnex plans to commercialize the results of this joint research as new testing services and launch them in the market. Even after the research concludes, Cowellnex will continue accumulating data and studying ways to utilize them, contributing to improving testing accuracy and developing ingredients that help regulate gut microbiota. By leveraging its strength in high-precision data obtained through shotgun metagenomic analysis, Cowellnex will accelerate innovation in the gut microbiota domain and create a market for personalized gut health solutions based on gut microbiota composition.

Alliance for Regenerative Medicine, 2026 Cell & Gene Meeting on the Mediterranean, Apr 28, 2026 through Apr 30, 2026. Venue: Rome Cavalieri, Salone dei Cavalieri, Section 1, Rome, Italy.

Kyowa Kirin Co., Ltd. reported earnings results for the full year ended December 31, 2025. For the full year, the company reported sales was JPY 496,826 million compared to JPY 495,558 million a year ago. Net income was JPY 67,040 million compared to JPY 59,870 million a year ago. Basic earnings per share from continuing operations was JPY 128.07 compared to JPY 113.06 a year ago. Diluted earnings per share from continuing operations was JPY 128.07 compared to JPY 113.06 a year ago.

Kyowa Kirin Co., Ltd. announced that, at a meeting of the Board of Directors, it was resolved to submit a proposal for "Partial Amendment to the Articles of Incorporation" to the Ordinary General Meeting of Shareholders scheduled to be held on March 19, 2026.

Kyowa Kirin Co., Ltd. announced leadership and Audit & Supervisory committee changes. Executive Personnel leaving the position: Four Audit & Supervisory Board Members are leaving their positions, effective upon the resolution at the Annual General Meeting of Shareholders scheduled to be held in March 2026: Hiroshi Komatsu (Audit & Supervisory Board Member (Full-time)); Hajime Kobayashi (Outside Audit & Supervisory Board Member (Full-time)); Mayumi Tamura (Outside Audit & Supervisory Board Member); Toru Ishikura (Audit & Supervisory Board Member). Additionally, Executive Officers are leaving their positions, effective upon the resolution at the Annual General Meeting of Shareholders scheduled to be held in March 2026: Motohiko Kawaguchi (Managing Executive Officer, Chief Financial Officer (CFO), Responsible for Corporate Communications Department Procurement Department, Administration of Finance and Accounting Department); Hiroshi Sonekawa (Managing Executive Officer, Vice President, Head of Sales & Marketing Division); Fumihiko Kanai (Executive Officer).

Kyowa Kirin Co., Ltd. provided consolidated earning guidance for the fiscal year ending December 31, 2026. For the year, the company expects revenue of JPY 520,000 million, core operating profit of JPY 100,000 million, profit of JPY 75,000 million, basic earnings per share of JPY 143.27, core profit of JPY 80,000 million and basic core earnings per share of JPY 152.82.

Kyowa Kirin Co., Ltd. expected to report Q1 2026 results on May 7, 2026. This event was calculated by S&P Global (Created on April 23, 2026).

Kyowa Kirin Co., Ltd., Annual General Meeting, Mar 19, 2026.

Kyowa Kirin Co., Ltd., Board Meeting, Feb 09, 2026. Agenda: To resolve to change the Company’s dividend policy.

Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program

Kyowa Kirin Co., Ltd., 2025 Earnings Call, Feb 10, 2026

Kyowa Kirin Co., Ltd., Board Meeting, Dec 11, 2025. Agenda: To consider and approve to nominate a change in Chief Executive Officer (CEO).

Biotechnology Innovation Organization, BIO Investment & Growth Summit, Mar 02, 2026 through Mar 03, 2026. Venue: Eden Roc Miami Beach, Miami Beach, Florida, United States.

Kura Oncology, Inc. and Kyowa Kirin Co. Ltd. announced new data demonstrating a favorable safety profile and encouraging antileukemic activity for KOMZIFTI (ziftomenib) in combination with venetoclax and azacitidine (ven/aza) for the treatment of acute myeloid leukemia (AML) harboring NPM1-m) or KMT2A-r AML. The ongoing KOMET-007 Phase 1a/1b trial evaluated patients in cohorts with newly diagnosed chemotherapy-ineligible AML and relapsed/refractory (R/R) AML. The new data are being reported in two oral presentations at the 67th Annual Meeting of the American Society of Hematology (ASH 2025). KOMZIFTI's potential benefit in challenging settings; the potential for KOMZIFTI to be integrated into front-line and relapsed/refractories regimens through ongoing registrational trials; the potential of KOMZIFTI to become a foundational, best-in-class menin inhibitor for patients with AML; the potential of KOM Ziftomenib in combination with venetoclAX and azacitidine to have a favorable safety profile; the pace and quality of enrollment of patients in Kura's KOMET-017 trials; and the potential of KOMZifTI to be combined with approved therapies and benefit a broad spectrum of patients earlier in their disease course. Factors that may cause actual results to differ materially include the risk that KOMZIFTI does not demonstrate safety and/or efficacy when used in combination with venetoclx and azacitidine in Kura's registrational KOMET-017 trials. The risk that Kura may not obtain approval to market KOMZIFTI in combination with venetoclix and azacitidine; uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the favor of building a business around such drugs.

Kyowa Kirin Co., Ltd. announced that they will report fiscal year 2025 results on Feb 09, 2026

Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced KOMZIFTI (ziftomenib), the first and only once-daily oral menin inhibitor to be approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 2A recommended treatment option for adults with relapsed/refractory AML with NPM1 mutation. KOMZIFTI received full approval by the U.S. Food and Drug Administration on November 13, 2025, for the treatment of adults with relapsed or ref refractory AML with a susceptible NPM1 mutations who have no satisfactory alternative treatment options. The approval was supported by data from the KOMET-001 clinical trial, including a 21.4% CR/CRh rate and median duration of CR/CRh response of 5 months. KOMZIFTI is now commercially available to prescribers in the U.S. and is available for purchase from a limited network of specialty pharmacies and distributors.

On November 13, 2025, Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced that the U.S. Food and Drug Administration has granted full approval of KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia (AML") with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. NPM1 mutations are among the most common founder mutations in AML, occurring in approximately 30% of cases. Historically, approximately 20% of patients with NPM1-m AML do not respond to front-line therapy. Of those who do respond, 70% will relapse within three years, most within 12 months. Early relapse and declining survival with each recurrence underscore the urgent need for treatment approaches that deliver lasting remission. Approval is supported by the pivotal KOMET-001 trial (NCT04067336), which evaluated KOMZIFTI's safety and efficacy in 112 R/R NPM1-m AM L patients. The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh") was 21.4% (95% CI: 14.2, 30.2). The median duration of CR+CRh was 5.0 months (95% CI: 1.9, 8.1) and the median time to first response in patients who achieved a CR or CRh was 2.7 months (range: 0.9 to 15 months). 88% of patients who achieved CR or CRh did so within six months of initiating KOMZIFTI. These data from the Prescribing Information are generally consistent with findings recently published in the Journal of Clinical Oncology on September 25, 2025. The most common adverse reactions (20%), including laboratory abnormalities, were aspartate aminotransferase increased, infection without an identified pathogen, potassium decreased, albumin decreased, alanine aminot Transferase increased, sodium decreased, creatinine increased, alkaline phosphatase increased, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, bilirubin increased, potassium increased, potassium increased, differentiation syndrome, pruritus, febrile neutropenia, and transaminases increased. KOMZIFTI includes a Boxed Warning for differentiation syndrome, a well-studied mechanism-based risk in drugs that restore differentiation.Absence of clinically meaningful drug-drug interactions can ease the use of KOMZIFTI with concomitant therapies, including those that cause QTc interval prolongation. QTc interval prolongation was Grade 3 in 12% of patients and no Grade 4 or Grade 5 QTc interval prolongation were reported. QTc interval prolongedation of any cause occurred in 10% of the 70 patients 65 years of age or older. The Company has set a wholesale acquisition cost for a one-month supply of KOMZIFTI at $48,500. In November 2024, the Company and Kyowa Kirin entered into a global strategic collaboration to develop and commercialize KOMZIFTI. The collaboration builds on Kyowa Kirin's leadership and expertise in hematologic malignancies. Under the terms of the collaboration, the Company leads development, regulatory and commercial strategy in the United States and is responsible for manufacturing KOMZIFTI.

Kyowa Kirin Co., Ltd. announced the appointment of Julie Dehaene-Puype as President for the Region, effective 1 November 2025. Julie follows the tenure of Jeremy Morgan, who has served as President for the International Region since 2023. Morgan will serve in an advisor role to the business through to the end of 2025, working in partnership with Dehaene-Puype to ensure a successful and smooth change for the company. Julie Dehaene-Puype joins Kyowa Kirin with more than 25 years of experience in the global pharmaceutical industry spanning general management, commercial operations, new product development and regulatory affairs. Julie’s background encompasses roles across a number of global pharmaceutical organisations including Mundipharma, Takeda, Merck/MSD, and Schering-Plough. Julie also sits on the board of Lytix Biopharma as a Non-Executive Director. Julie has a PharmD, a Masters in Pharmaceutical Regulatory Affairs and a Masters in Biological and Medical Sciences from the University of Lille, France. She has lived and worked in France, Belgium, Switzerland and the US. Currently, she resides in Switzerland, and she will be regularly present in the Marlow, UK headquarters as well as in the country offices throughout the region. The leadership change announced echoes role changes across the wider company. Earlier in the year, the global entity announced a new dual CEO-COO leadership structure to help support the business’ continued growth, with Abdul Mullick appointed President and COO, to oversee the execution of all business operations at the global level.

Kyowa Kirin Co., Ltd. proposed amendments to the Articles of Incorporation at the Annual Shareholders Meeting scheduled for March, 2026.

Kyowa Kirin Co., Ltd. expected to report Fiscal Year 2025 results on February 6, 2026. This event was calculated by S&P Global (Created on October 31, 2025).

Kyowa Kirin Co., Ltd., Board Meeting, Oct 30, 2025. Agenda: To consider the Announcement regarding the Transition to Company with Audit and Supervisory Committee.

Kyowa Kirin Co., Ltd., Q3 2025 Earnings Call, Oct 30, 2025

2025 Sustainability meeting