Mirvetuximab soravtansine

ORZEYFUL TM approved in the U.S., Japan and China for narcolepsy type 1 (NT1), MIMRYLO TM launched in the U.S. for erythrocytosis in polycythemia vera (PV) Zasocitinib advances to U.S. Food & Drug Administration (FDA) Priority Review and European Medicines Agency (EMA) review Late-stage pipeline continues to advance FY2026 full-year outlook upgraded to reflect foreign exchange (FX) benefit Takeda will host a Capital Markets Day on Dec. 11, 2026, in Tokyo, Japan OSAKA, Japan--(BUSINESS WIRE)--Takeda ( TOKYO:4502/NYSE:TAK ) announced financial results for the first half of fiscal year 2026 (April 1, 2026, to Sept. 30, 2026). The period included the approval of ORZEYFUL (oveporexton) in the U.S., Japan and China, the U.S. launch of MIMRYLO (rusfertide), progress in the regulatory review of zasocitinib, and additional clinical evidence across the late-stage pipeline. Takeda’s focus remains on execution against the first horizon of its growth strategy: successfully launching three new medicines, advancing its late-stage pipeline, ensuring resilience of core in-line brands and executing its transformation program. FY2026 First-Half Highlights Revenue increased by 8.4% versus the prior period on an actual exchange rates (AER) basis and decreased by 1.0% at constant exchange rates (CER). Core Operating Profit increased by 11.2% on an AER basis, and increased by 0.7% on a CER basis, supported by enterprise-wide transformation, which is helping fund growth investments. Reported Operating Profit increased by 60.4% on an AER basis reflecting the end of the amortization period for VYVANSE® intangible assets and lower impairment charges. Core EPS was 308 JPY, an increase of 10.5% at AER and decrease of 1.2% at CER. Reported EPS was 193 JPY, an increase of 169.0% at AER. Adjusted Free Cash Flow was JPY 325.7 billion. ORZEYFUL’s approvals in the U.S., Japan and China, together with the U.S. launch of MIMRYLO, mark significant progress toward Takeda’s near-term commercial priorities. ORZEYFUL is now available in Japan and China; its U.S. launch remains subject to Drug Enforcement Administration (DEA) scheduling. MIMRYLO launched in the U.S. in August 2026 and is now available to patients. The FDA accepted the New Drug Application (NDA) under Priority Review for zasocitinib; the EMA is also reviewing the application. Phase 3 head-to-head data in plaque psoriasis further strengthened the clinical evidence for zasocitinib. FY2026 full-year outlook upgraded to reflect FX benefit. Takeda President and Chief Executive Officer, Julie Kim, commented: “The launches of ORZEYFUL and MIMRYLO, combined with the acceptance of zasocitinib under Priority Review and its positive head-to-head Phase 3 data, represent a significant moment for Takeda and reflect strong execution against our two-horizon growth strategy.” “Our focus now is to translate these milestones into strong commercial execution, while continuing to advance our late-stage pipeline, ensuring resilience of our core in-line brands and unlocking capabilities through transformation. Progress against our priorities in Horizon One of our strategy is building the foundation for Takeda’s next phase of growth. We look forward to sharing more details on our growth strategy and how we will build sustainable leadership in our core therapeutic areas at our Capital Markets Day in December.” Takeda Chief Financial Officer, Milano Furuta, commented: “We are reinvesting transformation savings to support new product launches and advance our pipeline. Our first-half results demonstrate that we are on track in advancing our Horizon One priorities and we will continue our disciplined execution to deliver on our revised full-year forecast and management guidance.” FINANCIAL HIGHLIGHTS for First-Half Results ended September 30, 2026 (Billion yen, except percentages and per share amounts) Item FY2026 H1 (Billion JPY) FY2025 H1 (Billion JPY) YoY (AER) Revenue 2,407.0 2,219.5 +8.4% Operating Profit 406.7 253.6 +60.4% Margin 16.9% 11.4% +5.5pp Net Profit 305.6 112.4 +171.8% EPS (Yen) 193 72 +169.0% Operating Cash Flow 431.9 593.7 -27.2% Adjusted Free Cash Flow (Non-IFRS) 325.7 525.4 -38.0% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) Item FY2026 H1 FY2025 H1 YoY (AER) YoY (CER) Revenue 2,407.0 2,219.5 +8.4% -1.0% Operating Profit 710.6 639.2 +11.2% +0.7% Margin 29.5% 28.8% +0.7pp Net Profit 489.6 438.6 +11.6% -0.2% EPS (Yen) 308 279 +10.5% -1.2% FY2026 Full-year Forecast and Guidance Takeda raised its FY2026 outlook mainly due to FX benefit. (Billion yen, except percentages and per share amounts) Item FY2026 ORIGINAL MANAGEMENT GUIDANCE AT CER (MAY 2026) FY2026 REVISED MANAGEMENT GUIDANCE AT CER (OCT 2026) Core Revenue Low-single digit % decline Low-single digit % decline Core Operating Profit 5% to 8% decline Mid-single digit % decline Core EPS (Yen) Mid-teens % decline Low-teens % decline Item FY2026 ORIGINAL FORECAST (MAY 2026) FY2026 REVISED FORECAST (OCT 2026) Revenue 4,640.0 4,700.0 Core Revenue (Non-IFRS) 4,640.0 4,700.0 Operating Profit 420.0 453.0 Core Operating Profit (Non-IFRS) 1,160.0 1,190.0 Net Profit 166.0 209.0 EPS (Yen) 104 131 Core EPS (Yen) (Non-IFRS) 472 482 Adjusted Free Cash Flow (Non-IFRS) 650.0 – 750.0 700.0-800.0 Annual dividend per share (Yen) 204 204 New Medicines and Late-Stage Pipeline Progress New medicine approvals and late-stage pipeline progress during the first half of FY2026 reinforce progress against Takeda’s strategic priorities. The following updates highlight key milestones. ORZEYFUL An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1). Launched in Japan and China for adults with NT1 on October 15; U.S. commercial launch remains subject to DEA scheduling, expected in early November 2026. Phase 3 results were published in the New England Journal of Medicine , demonstrating significant improvements across key symptoms and quality-of-life measures. MIMRYLO First-in-class hepcidin mimetic approved in the U.S. for the treatment of erythrocytosis in adults with polycythemia vera (PV); launched in August. MIMRYLO has been shown to maintain hematocrit control, the primary treatment goal in PV, as well as reduce phlebotomy burden and alleviate symptoms including fatigue. Approval supported by Phase 3 VERIFY results showing 76.9% of patients achieved clinical response during weeks 20-32. MIMRYLO is the only treatment to be recommended as a Category 1 option across low- and high-risk PV in the National Comprehensive Cancer Network® (NCCN®) clinical practice guidelines in oncology for myeloproliferative neoplasms. Zasocitinib The FDA accepted the NDA under Priority Review for adults with moderate-to-severe plaque psoriasis; the EMA also accepted the Marketing Authorization Application for review. Phase 3 demonstrated superiority to deucravacitinib on the primary and all key secondary efficacy endpoints; more than 2.5 times as many patients achieved complete skin clearance. Zasocitinib remains investigational, with commercial launch planning underway, subject to regulatory approval. Broader Oncology Pipeline At the European Society for Medical Oncology (ESMO), Takeda presented positive Phase 3 results showing that arcotatug tavatecan (TAK-921) delivered statistically significant and clinically meaningful improvements in overall survival and progression-free survival in patients with advanced gastric cancer. The findings support a regulatory filing in Japan in FY2027 and continued global development of arcotatug tavatecan in CLDN18.2-positive cancers. Development of TAK-928 continues, including through a global Phase 3 study in patients with immunotherapy-resistant squamous NSCLC. Takeda also recently announced that it will expand this study to include a new sub-trial for patients with non-squamous NSCLC. ELAHERE® (mirvetuximab soravtansine) was approved in Japan for folate receptor alpha-positive, platinum-resistant recurrent ovarian cancer. Transformation, Capital Allocation and Shareholder Returns Takeda continues to make solid progress on its enterprise transformation, a key FY2026 priority alongside the launch of new medicines and the advancement of its R&D pipeline. These efforts are designed to enhance operational efficiency, strengthen capabilities and optimize resource allocation, and support near-term execution under Horizon One of Takeda’s two-horizon growth strategy, while laying the foundation for sustainable growth under Horizon Two. Takeda maintains a disciplined capital allocation framework that prioritizes investment in new product launches and innovation, while maintaining its commitment to shareholder returns through its progressive dividend policy. Additional Information Regarding FY2026 First Half Results Takeda will host a conference call for investors and analysts on Thursday, Oct. 29, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first half results. A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website ( ). The presentation materials include details on Takeda’s FY2026 first half results, business progress and pipeline updates, as well as definitions of non-IFRS measures. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. 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These expressions are also used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Financial information and Non-IFRS Measures Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit for the year attributable to owners of the Company, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, Adjusted Net Debt, EBITDA, Adjusted EBITDA, Free Cash Flow and Adjusted Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS measures to their most directly comparable IFRS measures, which are in the Financial Appendix appearing at the end of our FY2026 H1 investor presentation (available at ). Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Contacts Investor Relations Christopher O’Reilly Takeda.ir.contact@takeda.com Media Relations Corporate Communications toiawase_kouhou@takeda.co.jp (Tokyo) media_relations@takeda.com (Boston)

伦敦 2026年10月7日 /美通社/ -- 处于临床开发阶段的非上市制药公司 OncoBayes 今日宣布，已顺利完成 OB-001 的临床前研究。研究结果表明，该药物有潜力满足肿瘤治疗领域两项亟待解决的临床需求：克服抗体偶联药物（ADC）耐药性，以及提升酪氨酸激酶抑制剂（TKI）的入脑能力。 OB-001 可高选择性、高效地抑制 P-糖蛋白（P-gp）和乳腺癌耐药蛋白（BCRP）这两种关键外排泵，二者均存在于血脑屏障和肿瘤细胞表面。该药物正以每日服用一次的口服片剂形式进行开发，拟与多种公认的标准抗肿瘤疗法联合使用，以优化这些疗法的疗效。 在采用脑灌流处理的小鼠研究中，预先给予 OB-001 可显著提高四种标准治疗用激酶抑制剂的脑内暴露量，而全身（血浆）暴露量基本保持不变。在 2026 年美国癌症研究协会（AACR）年会上公布的数据显示，OB-001 可使奥希替尼的脑内暴露量提高近 400%，而全身暴露量的变化极小 [1],[2] 。基于奥希替尼的转化药代动力学—药效学—肿瘤生长抑制（PK-PD-TGI）模型预测，脑内暴露量的上述提升有望大幅延长 EGFR 突变型非小细胞肺癌（EGFRm NSCLC）患者的中枢神经系统（CNS）无进展生存期。更有效地控制脑转移，仍是非小细胞肺癌和乳腺癌治疗中亟待满足的重要临床需求。 这两种外排泵也已被证实是导致 ADC 耐药的关键机制之一：外排泵过度表达会降低肿瘤内的药物载荷浓度。采用双向转运试验开展的临床前研究表明，OB-001 可减少多种主流 ADC 药物载荷的外排，包括戈沙妥珠单抗（Trodelvy®）所使用的 SN-38、索米妥昔单抗（Elahere®）所使用的 DM4，以及德曲妥珠单抗（Enhertu®）所使用的 DXd。 目前，公司正筹备开展并行临床试验，以获取 OB-001 与奥希替尼联合用药的概念验证（POC）数据，同时评估其能否恢复肿瘤对德曲妥珠单抗（T-DXd）的敏感性。 OncoBayes 首席执行官 Jim Millen 表示：“这是我们团队取得的一个关键里程碑，如今我们已为启动 OB-001 的临床研究计划做好充分准备。” “OB-001 有望成为同类首创药物，作为一种使用方便的口服辅助用药，与多种重磅抗肿瘤疗法联合使用，具有广泛的应用潜力。这确实是一个通过单一产品拓展多条研发管线的机会。” 参考文献： 1. AACR 2026 年会摘要 5873。2026 年 4 月 1 日；86(7_Supplement)：5873。 https://doi.org/10.1158/1538-7445.AM2026-5873 . 2. Cancer Research Communications, 2026 年 5 月 1 日；6 (5): 1213–1219。 https://doi.org/10.1158/2767-9764.CRC-25-0553 . 联系方式：Mark Brimble， mbrimble@oncobayes.com<\/a> <\/p>