Takeda Pharmaceutical Company Ltd (TAK)

U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's DiseaseJune 9, 2026 4:30 PM
Business Wire If approved, ENTYVIO would be the only gut-focused treatment for patients two years and older with moderately to severely active ulcerative colitis (UC) or Crohn's disease Potential for ENTYVIO to address pediatric treatment gaps, reflecting Takeda’s commitment to advancing options where unmet treatment needs remain Takeda (TSE:4502/NYSE:TAK) today announced the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for intravenous (IV) ENTYVIO® (vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease in pediatric patients ages 2 years and older. If approved, ENTYVIO would be the only gut-focused treatment option for these patients. This milestone reflects Takeda's deep commitment to this patient community and its role in advancing care and addressing unmet needs in UC and Crohn's. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of calendar year 2027. “A child or teen diagnosed today with UC or Crohn’s disease has decades of medical treatment ahead and represents one of the most challenging to treat patient populations in pediatric gastroenterology. Yet, historically, therapeutic options for this age group have been limited,” said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit. “There is a need for additional treatments that can achieve clinical remission. The efficacy and safety profile of ENTYVIO is well-established in adults with more than a dozen years of scientific study and clinical data. We’re confident that, if approved, ENTYVIO IV would contribute to addressing the unmet needs in the treatment of pediatric UC and Crohn’s disease.” UC and Crohn’s disease, the two most common forms of inflammatory bowel disease (IBD),1 are lifelong, relapsing, remitting, inflammatory diseases of the gastrointestinal tract.2,3 In approximately 25 percent of patients, IBD is diagnosed before age 20, and its prevalence among children and adolescents around the world continues to rise.4,5 Children with IBD often develop more extensive disease compared to their adult counterparts.6 Takeda is committed to supporting this vulnerable patient population with evidence-based therapies. Takeda has also submitted a marketing authorization application (MAA) to the European Medicines Agency for ENTYVIO IV for the treatment of moderately to severely active UC and Crohn’s disease in pediatric patients ages 2 years and older, and plans to submit applications in additional markets later this year. The sBLA and MAA are supported by data from two randomized, double-blind, multicenter Phase 3 pediatric trials in patients ages 2 to 17 years—the KEPLER study (NCT: 04779307; EudraCT: 2020-004300-34) in UC and the ongoing WEBB study (NCT: 04779320; EudraCT: 2020-004301-31) in Crohn’s disease. The primary endpoint for KEPLER was clinical remission at Week 54 among patients who achieved a clinical response following vedolizumab IV induction, while WEBB had co-primary endpoints of clinical remission and endoscopic response at Week 54.7,8 ENTYVIO is currently approved for the treatment of moderately to severely active UC and Crohn’s disease in adults. About ENTYVIO® (vedolizumab)
ENTYVIO, a biologic therapy, is the only gut-focused treatment available for ulcerative colitis and Crohn’s disease in adults. It specifically binds to the a4ß7 integrin and blocks its interaction with MAdCAM-1, which is mainly expressed on the gut endothelial cells.9 ENTYVIO is approved for IV and subcutaneous (SC) administration in adults with moderately to severely active ulcerative colitis and Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFa) antagonist (approvals vary by market).10,11 Marketing authorization has been granted in more than 80 countries for ENTYVIO IV and in more than 50 countries for ENTYVIO SC. Globally, ENTYVIO IV and SC have more than 1.9 million patient years of exposure to date.12 IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. WARNINGS AND PRECAUTIONS Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate, have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment. Infections: ENTYVIO increases the risk for developing infections. Serious infections in clinical trials included anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. Postmarketing reports include systemic bacterial, fungal, viral, and parasitic opportunistic infections. Do not start ENTYVIO in patients with a clinically important active infection until resolved or adequately treated. In patients with chronic infection or history of recurrent infection, consider risks and benefits prior to ENTYVIO. Instruct patients to seek medical advice if signs or symptoms of acute or chronic infection occur. If a serious infection develops or does not respond to therapy, monitor closely and do not administer ENTYVIO until resolved. Tuberculosis: Consider evaluating for TB prior to ENTYVIO. Do not administer ENTYVIO to patients with active TB. Before starting ENTYVIO, treat latent TB and consider anti-TB therapy in patients with a history of TB if adequate course of treatment cannot be confirmed. Monitor for active TB during and after ENTYVIO. Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently. Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury. Immunizations: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks. ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration. DRUG INTERACTIONS
Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed. INDICATIONS
ENTYVIO is indicated in adults for the treatment of: Moderately to severely active ulcerative colitis (UC) Moderately to severely active Crohn’s disease (CD) DOSAGE FORMS & STRENGTHS: ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab Please click for Full U.S. Prescribing Information. 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 www.takeda.com. 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 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. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. 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” 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; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; 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, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); 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: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. 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. 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. References 1 Baumgart DC, Carding SR. Lancet. 2007;369:1627-1640. 2 Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Lancet. 2017; 389(10080):1741-1755. 3 Krugliak N, Torres J, Rubin DT. Gastroenterology. 2022;162:1396-1408. 4 Kuenzig ME, Fung SG, Marderfeld L, et al. Gastroenterology. 2022;162(4):1147-1159.e4. 5 Rosen M, Dhawan A, Saeed S. JAMA Pediat. 2015;169(11): 1053–1060. 6 Moon J. Pediatr Gastroenterol Hepatol Nutr. 2019. 7 A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04779307. Last accessed May 26, 2026. 8 A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04779320?tab=study. Last accessed May 26, 2026. 9 Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330(3):864-875. 10 ENTYVIO (vedolizumab) Prescribing Information. Takeda Pharmaceuticals. Available at: https://content.takeda.com/?contenttype=PI&product=ENTY&language=ENG&country=USA&documentnumber=1. 11 ENTYVIO Summary of Product Characteristics (SmPC). Takeda Pharmaceuticals. Available at: https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf. 12 Data on file. Takeda Pharmaceuticals.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260608352333/en/ Media Contacts:
Takeda Media Relations
media_relations@takeda.com Original: U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's Disease

Takeda Announces FY2025 Full Year Results and FY2026 Outlook, Highlighted by Excellent Pipeline Progress and Solid FY2025 ResultsMay 13, 2026 2:38 AM
Business Wire FY2025 Pipeline Successes Set the Stage for Pivotal Product Launches Achieved Latest FY2025 Management Guidance Takeda is Entering a New Era & Transforming for Growth Acceleration   Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the fiscal year 2025 (period ended March 31, 2026). The Company delivered solid results in line with its latest FY2025 Management Guidance, reflecting strong OPEX savings, mitigating revenue headwinds while continuing to invest in future growth. Key Highlights for FY2025 Revenue decreased by 1.7% YoY at actual exchange rates (AER), resulting from the loss of exclusivity for VYVANSE® which was partially mitigated by Growth and Launch Products. On a Core basis, Revenue decreased by 2.6% at Constant Exchange Rate (CER). Core Operating Profit increased by 0.8% YoY at AER and declined by 0.9% at CER, protected by OPEX savings, while still investing for growth. Reported Operating Profit increased by 19.3% YoY at AER, also reflecting a step-down in amortization expenses for VYVANSE and lower restructuring expenses. Core EPS increased by 5.2% YoY at AER and by 3.1% at CER, while reported EPS increased by 78.1% YoY. Adjusted Free Cash Flow amounted to JPY 684.5 billion, in line with forecast, and the Company ended fiscal year with strong cash balance. Delivered key milestones for oveporexton, rusfertide, and zasocitinib, with positive Phase 3 readouts; completed regulatory submissions for oveporexton and rusfertide, and launch preparations underway. Takeda Chief Executive Officer (CEO)-elect, Julie Kim, commented:
“FY2025 was a pivotal year, validating the strength of our execution against demanding development and regulatory milestones, the resilience of our commercial portfolio and our strong position with three major launches planned in the next 12 months and the most robust late-stage pipeline in our history. Our growth roadmap is built around two strategic horizons: transforming for growth through near-term launches and strengthening competitiveness and accelerating growth by transitioning to a new cohort of blockbuster brands, together positioning us for long-term profitable growth and patient impact.” Takeda Chief Financial Officer, Milano Furuta, commented:
“In FY2025, despite topline headwinds, we delivered solid profit and cash flow through disciplined cost control, while directing growth investment toward new product launches and the pipeline. In FY2026, we will continue to focus on transforming operations and protecting profitability while delivering successful launches and advancing our pipeline. Strong cash flow generation and deleveraging will support long-term investment for growth acceleration and ensure competitive returns for our shareholders.” Full-year FY2026 Forecast and Guidance
Based on the current business outlook and planned investment profile, Takeda issued the following FY2026 forecast and management guidance. (Billion yen, except percentages and per share amounts) Item FY2026
FORECAST FY2026 MANAGEMENT GUIDANCE Core Change at CER (Non-IFRS) Revenue 4,640.0 --- Core Revenue (Non-IFRS) 4,640.0 Low- single digit % decline Operating Profit 420.0 --- Core Operating Profit (Non-IFRS) 1,160.0 5% ~ 8% decline Net Profit 166.0 --- EPS (Yen) 104 --- Core EPS (Yen (Non-IFRS) 472 Mid-teens % decline Adjusted Free Cash Flow (Non-IFRS) 650.0-750.0 --- Annual Dividend per Share (Yen) 204 --- Pipeline Achievements Set the Stage for Future Growth
Our three leading late-stage assets are positioned for regulatory approvals in the U.S. and other geographies in FY2026-2027. We expect this will be a pivotal period for launches and investment with clear near-term wins and proof points over the next 12–24 months. oveporexton: Oveporexton is potentially a first-of-its-kind orexin agonist designed to address the underlying orexin deficiency that causes narcolepsy type 1. Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for oveporexton in the second half of 2026 and has also completed regulatory filings in Japan and China. rusfertide: Rusfertide is a potential first-in-class hepcidin mimetic that has demonstrated rapid, stable, and durable hematocrit control in patients with polycythemia vera, or PV, and has the potential to shift the standard of care in this blood cancer. Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for rusfertide in the second half of 2026. zasocitinib: Zasocitinib is poised to be a leading oral treatment option for psoriasis patients with the potential to significantly expand the oral segment in a growing psoriasis market. Takeda is making decisive investments to support a planned regulatory filing in 2026 and a commercial launch in the first half of 2027. FINANCIAL HIGHLIGHTS for FY2025 Ended March 31, 2026 (Billion yen, except percentages and per share amounts) Item FY2025 (Billion JPY)   FY2024 (Billion JPY)   YoY Growth (AER) Revenue 4,505.7   4,581.6   -1.7% Operating Profit 408.8   342.6   +19.3% Margin 9.1%   7.5%   +1.6pp Net Profit 191.8   107.9   +77.7% EPS (Yen) 122   68   +78.1% Operating Cash Flow 1,041.4   1057.2   -1.5% Adjusted Free Cash
Flow (Non-IFRS) 684.5   769.0   -11.0% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) Item FY2025 (Billion JPY) FY2024 (Billion JPY) YoY Growth (AER) YoY Growth (CER) Revenue 4,505.7   4,579.8   -1.6%   -2.6% Operating Profit 1,172.5   1,162.6   +0.8%   -0.9% Margin 26.0%   25.4%   +0.6pp   --- Net Profit 814.1   775.6   +5.0%   +2.9% EPS (Yen) 517   491   +5.2%   +3.1% Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation to drive growth and enables the company to deliver returns to shareholders under its progressive dividend policy. In FY2025, the proposed annual dividend was JPY 200 per share, and year-end adjusted net debt/adjusted EBITDA was 2.6x. Additional Information About Takeda’s FY2025 Results
Takeda will host a conference call for investors and analysts on Wednesday, May 13, 2026, at 7:00 PM JST / 6:00 AM EDT to discuss its full-year 2025 financial results. A live webcast of the conference call, along with presentation materials, will be available on the investor relations section of Takeda’s website at www.takeda.com/investors. The presentation will contain further details on Takeda’s FY2025 results, commercial progress, pipeline updates, and other financial information, including key assumptions for the FY2026 forecast and 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 https://www.takeda.com. 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. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. 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: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. 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 FY2025 Q4 investor presentation (available at www.takeda.com/investors). 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. Please refer to slide 14 of Takeda’s FY2025 Q4 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products. View source version on businesswire.com: https://www.businesswire.com/news/home/20260510786927/en/ Investor Relations
Christopher O’Reilly

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TAK-881-3001??????????????????·?????????????·L·???????(MD?PhD)??????????????PID??????????IG?????????????????????????????????????????????????????????????????????????????TAK-881-3001???????????????????????????????????IG????PID????????????????????????????????????????????????????????????? TAK-881-3001??????????????????????????????????????????????????2026???????????????????TAK-881?????????????? TAK-881-3001???TAK-881-3002???? TAK-881-3001?????????(IG)????????????????2???????????????(PID)???????TAK-881??????????????????????????????2/3??????????????????????????????16???????????TAK-881????HYQVIA??????????HYQVIA????TAK-881????????????????IG????????????????51??????????????????????2???16????????TAK-881?????27?????????TAK-881-3001???????????ClinicalTrials.gov???????NCT05755035???????? TAK-881-3002??PID??????TAK-881??????????????????3???????TAK-881-3001????????TAK-881-3002???????????ClinicalTrials.gov???????NCT06076642???????? TAK-881???? TAK-881[????????????20%??(SCIG 20%)???????????????????]?????????(IG)20%?????1???Halozyme?????????????????(rHuPH20)?????1??????????????????????IG??????????????TAK-881?????????????????????????????????????????????????????1????????????????????????TAK-881?????????????SCIG 20%????PID??????????????????????????????????????????????????? ????????(PID)???? ????????(PID)???????????????????????????????????550?????????????????1?????????????????????????????2PID???????????????/???????????????????????????????????????????????????????????????????3??????1,200??1??PID?????????4 HYQVIA®???? HYQVIA®[????????????????????????????????10%]?????????(IG)10%?Halozyme?????????????????(rHuPH20)??????????HYQVIA????????(EMA)???????????????????????(PID)???????????(0~18?)???????????????????????????????????????????????(PSAF)??????????????IgG???4g/L?????????????(SID)????????????????????????????????????????(CIDP)???????????(0~18?)??????IG??(IVIG)???????????????EMA???????????? ?????HYQVIA? ?????2???????PID??????????????CIDP????????????????????????? HYQVIA?????????????????????IG?????????IG????????????????HYQVIA????????????????????????????IG?????????????HYQVIA?????1?(CIDP??2?3???4????PID??3???4???)??????? HyQvia®(???????????)100mg/mL???????? ????????(????) ?????????????????????????HyQvia(???????????(SCIg))???????(SmPC)?????????? ??????:????????????????????/CIDP?????????????????????????????????(SC)?????????????????????????????????????????PK???????????????????????????????????????????????????????????????????? ??:???????????????????????????????????????????????IgA????????????????IgA??????????????????????????????????????rHuPH20??????????? ???????:??:???????(0~18?)???????????????????????????????????SmPC?????????????????????????????????????:?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????:????????????????????????????????????????????????????????????????????? ???????????????? : ?????????:???????????????????????????????????????????????????????????:HyQvia?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????20?????????????????????????????????????????????????????????????????????/???????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????IG 10%???????: ?IgA??????SCIg??????????????????????????????????HyQvia???????????????????????????????????????????????????????????????????????????????????????????????????????SmPC??????????rHuPH20???????:rHuPH20??????????????????????????????????????????????????????????????????????rHuPH20?????:?????HyQvia??????????????rHuPH20????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????:???????????????????????????????(A?B?D??)???????????????????????????????????????????????????????????????????????(AMS):IVIg???SCIg????????????????????????????????????????2??????????????????????????????????????????????AMS???????????????????????AMS?????(2g/kg)?IVIg?????????????????????????????????AMS??????????????????????????AMS??????????????????????????????:???????????????????????????????????????????????????????????????????????????????????????????????????????ß-D-??????????????????????????????????????:????????????????????????????????????????????????????????????????????????????????????????????????????/????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ????:???????????????????????????????????????????????6??????3???????????????????????????????????????????????3??????????????????????????????1??????????????????????????????????????????????????? ???:????????????(AR)????????????????????????(AR)???????????????????????????????????????????????????????????????????????????????????????/???????????????????????1??????????:?????????(1/10??):????(??????????????????SmPC???);??????(1/100??1/10??):????????????????????????????????????????????;???????(1/1,000??1/100??):??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????;??(1/10,000??1/1,000??):??????????????????????????????????????????????????????????????? EU?SmPC?????????????????: https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf ???????????????????????????: https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf ???????? ????????????????????????????????????????????????????????????????????????????????????????(??????)?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????(???)?????????????????????????????????????????????????????????????????????80???????????????????????????????????2????????????????????????????????? www.takeda.com. ???? ?????????????????????????(????????????????)??????????????(?????????)????????????????????????????????????????????????????????????(???????????????????????)??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????1933?????????????????????????????????????????????????????????????(????????????????????????)???????????????????????????????(???????????????????)?????????????????????????????????????????????????? ?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ??????????? ????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????(targets)???????(plans)??????(believes)?????(hopes)???????(continues)???????(expects)??????(aims)???????(intends)????????(ensures)??????(will)?????????(may)??????????(should)???????(would)?????????(could)????????(anticipates)??????(estimates)???????(projects)????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????(??????????????????????)?????????????????????????????????????????????????????????????????????????????????????????????(https://www.takeda.com/investors/sec-filings-and-security-reports/)??www.sec.gov???????????????????????????Form 20-F????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ???? ??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????   1Immune Deficiency Foundation. Living With Primary Immunodeficiency. 2026?4?????????:https://primaryimmune.org/living-primary-immunodeficiency. 2Center for Disease Control and Prevention. About Primary Immunodeficiency (PI). 2026?4?????????:https://www.cdc.gov/primary-immunodeficiency/about/index.html. 3Immune Deficiency Foundation. Understanding Primary Immunodeficiency. 2026?4?????????:https://primaryimmune.org/understanding-primary-immunodeficiency. 4 Kobrynski L, Powell RW, Bowen S. J Clin Immunol. 2014;34(8):954-961 ?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? businesswire.com????????????:https://www.businesswire.com/news/home/20260504591050/ja/ Media Contact:
Takeda Media Relations
media_relations@takeda.com Original: ?????????????(PID)??????TAK-881????2/3????????????????????

Takeda annonce les premiers résultats positifs d’un essai clinique pivot de phase 2/3 sur le TAK-881 dans le traitement des déficits immunitaires primaires (DIP)May 5, 2026 8:39 PM
Business Wire Le TAK-881, en cours d’étude, s’est révélé comparable au médicament de référence HYQVIA, tout en permettant une réduction du volume et de la durée de la perfusion chez les patients atteints de DIP Takeda ( TSE:4502/NYSE:TAK ) a annoncé aujourd’hui que l’essai clinique pivot de phase 2/3 TAK-881-3001, mené chez des patients atteints d’un déficit immunitaire primaire (DIP), a atteint son critère d’évaluation principal, démontrant la comparabilité pharmacocinétique (PK) entre le TAK-881 expérimental [immunoglobuline sous-cutanée (humaine), solution à 20 % (SCIG 20 %) avec hyaluronidase humaine recombinante] et HYQVIA [immunoglobuline pour perfusion (humaine) à 10 % avec hyaluronidase humaine recombinante]. De plus, les critères d’évaluation secondaires ont montré que le TAK-881, une SCIG à 20 % facilitée par l’hyaluronidase, présentait des profils de sécurité, d’efficacité et de tolérance comparables à ceux de l’HYQVIA, une SCIG à 10 % établie et facilitée par l’hyaluronidase. Ces résultats confirment le potentiel du TAK-881 à administrer la dose d’immunoglobulines (IG) requise pour les patients atteints de DIP dans un volume deux fois plus petit que celui d’HYQVIA, réduisant ainsi la durée de la perfusion tout en conservant une posologie flexible, pouvant aller jusqu’à une fois par mois pour les patients (toutes les trois ou quatre semaines pour les DIP). L’essai clinique TAK-881-3001 a évalué la pharmacocinétique, l’efficacité, la sécurité, la tolérance et l’immunogénicité du TAK-881 chez des adultes et des patients pédiatriques âgés de 2 ans et plus atteints de DIP et ayant déjà reçu un traitement par IG, et les a comparées à celles d’HYQVIA chez des patients âgés de 16 ans et plus. Les premières données clés montrent que le TAK-881 : A atteint une pharmacocinétique comparable : l’étude a atteint son critère d’évaluation principal, démontrant une exposition équivalente en immunoglobuline G (IgG) entre le TAK-881 et HYQVIA, comme le montre un rapport de moyenne géométrique de 99,67 % (IC à 90 % : 95,10 % à 104,46 %) pour les aires sous les courbes de concentration en fonction du temps sur un intervalle posologique à l’état d’équilibre (AUC0-tau,ss). A assuré une protection immunitaire : le TAK-881 a démontré des taux d’infection et une protection immunitaire comparables à ceux d’HYQVIA, avec des taux d’IgG protecteurs maintenus de manière constante tout au long de l’étude. A démontré un profil de sécurité comparable : les profils de sécurité et de tolérance du TAK-881 se sont révélés comparables à ceux d’HYQVIA, sans qu’aucun nouveau signal de sécurité n’ait été observé. Le profil de sécurité du TAK-881 continuera d’être évalué dans le cadre de l’étude de prolongation TAK-881-3002 en cours. « Ces résultats de phase 2/3 ont montré que le profil pharmacocinétique du TAK-881 était comparable à celui d’HYQVIA, une référence établie en matière de traitement par immunoglobulines chez les patients atteints de DIP, tout en offrant les avantages potentiels d’un nombre réduit de sites d’injection, d’un calendrier de traitement flexible et de durées de perfusion plus courtes », déclare Kristina Allikmets, vice-présidente principale et responsable de la R&D en thérapies dérivées du plasma chez Takeda. « L’étude TAK-881-3001 reflète notre engagement plus large en matière de R&D visant à faire progresser les traitements par IG de nouvelle génération et à proposer plus rapidement de nouvelles options thérapeutiques significatives aux patients, tout en élargissant leur choix et en respectant des normes rigoureuses d’efficacité et de sécurité. » Pour de nombreux patients atteints de DIP, le traitement substitutif par IG est la seule option thérapeutique permettant de maintenir une protection immunitaire contre les infections. Bien que les traitements par IG existants soient efficaces, de nombreux patients continuent de subir le fardeau du traitement, notamment des perfusions fréquentes ou à haut débit. « Les patients nécessitant un traitement à vie par IG pour une DIP subissent un fardeau thérapeutique important. L’amélioration du processus d’administration peut alléger ce fardeau en ayant un impact significatif sur l’expérience du traitement », déclare Richard L. Wasserman, allergologue/immunologiste et investigateur principal pour TAK-881-3001. « Ces premiers résultats de l’étude TAK-881-3001 sont encourageants. Ils montrent qu’une IG sous-cutanée hautement concentrée, facilitée par l’hyaluronidase, peut offrir une protection immunitaire tout en rendant l’expérience de perfusion plus facile à gérer, dans le but d’améliorer la vie quotidienne des patients atteints de DIP. » Les analyses de l’étude TAK-881-3001 sont en cours, et Takeda prévoit de partager des résultats supplémentaires lors d’un prochain forum médical. Takeda prévoit de soumettre des demandes d’autorisation pour le TAK-881 aux autorités réglementaires aux États-Unis, dans l’Union européenne et au Japon au cours de l’exercice 2026. À propos des études TAK-881-3001 et TAK-881-3002 TAK-881-3001 était un essai clinique pivot de phase 2/3 évaluant la pharmacocinétique, l’efficacité, la sécurité, la tolérance et l’immunogénicité du TAK-881 chez des adultes et des patients pédiatriques âgés de 2 ans et plus atteints d’un déficit immunitaire primaire (DIP) et ayant déjà reçu un traitement par immunoglobulines (IG). Les participants à l’étude âgés de 16 ans et plus ont été randomisés pour recevoir soit le TAK-881 suivi de l’HYQVIA, soit l’HYQVIA suivi du TAK-881, à la même dose et selon le même intervalle posologique que l’IG, pendant une durée maximale de 51 semaines, dans le cadre de la partie de l’étude ouverte, randomisée et croisée. Les participants âgés de 2 à moins de 16 ans ont été traités uniquement par le TAK-881 pendant une durée maximale de 27 semaines dans la partie de l’étude ouverte à bras unique. De plus amples informations sur l’essai clinique TAK-881-3001 sont disponibles sur ClinicalTrials.gov sous le numéro d’identification NCT05755035. L’étude TAK-881-3002 est une étude de phase 3 visant à évaluer la sécurité et la tolérance à long terme du TAK-881 chez les patients atteints d’un déficit immunitaire primaire (DIP) ; il s’agit de l’étude de prolongation de l’étude TAK-881-3001. De plus amples informations sur l’essai clinique TAK-881-3002 sont disponibles sur ClinicalTrials.gov sous le numéro d’identification NCT06076642. À propos du TAK-881 Le TAK-881 [immunoglobuline sous-cutanée (humaine), solution à 20 % (SCIG 20 %) et hyaluronidase humaine recombinante] est un médicament liquide expérimental composé d’un flacon d’immunoglobuline (IG) à 20 % et d’un flacon d’hyaluronidase humaine recombinante (rHuPH20) de Halozyme. L’IG est extraite du plasma humain et contribue au bon fonctionnement du système immunitaire. Le TAK-881 est administré par voie sous-cutanée dans le tissu adipeux sous-cutané, où l’hyaluronidase facilite la dispersion et augmente l’absorption de l’immunoglobuline dans le tissu sous-cutané, permettant ainsi l’administration de volumes plus importants au niveau d’un site d’injection donné. En tant qu’IGSC à 20 % facilitée par l’hyaluronidase, le TAK-881 est développé dans le but de réduire le volume et la durée de la perfusion tout en offrant une protection immunitaire efficace aux patients atteints de DIP. À propos des déficits immunitaires primaires (DIP) Les déficits immunitaires primaires (PID) constituent un groupe de plus de 550 maladies rares et chroniques, dans lesquelles une partie du système immunitaire de l’organisme est absente ou ne fonctionne pas comme elle le devrait.1 Ces affections résultent de mutations génétiques, qui sont généralement héréditaires.2 Les symptômes des PID varient et peuvent inclure des infections fréquentes et/ou persistantes ainsi qu’une auto-immunité inhabituelle, conduisant souvent à de longues périodes de diagnostic erroné malgré des consultations auprès de plusieurs spécialistes.3 Aux États-Unis, les PID touchent environ 1 personne sur 1 200.4 À propos d’HYQVIA® HYQVIA® [perfusion d’immunoglobulines à 10 % (humaines) avec hyaluronidase humaine recombinante] est un médicament liquide contenant 10 % d’immunoglobulines (IG) et l’hyaluronidase humaine recombinante (rHuPH20) de Halozyme. HYQVIA est approuvé par l’Agence européenne des médicaments (EMA) en tant que traitement de substitution chez les adultes, les enfants et les adolescents (0-18 ans) atteints d’un déficit immunitaire primaire (DIP) avec une protection anticorps déficiente et d’un déficit immunitaire secondaire (DIS) chez les patients souffrant d’infections graves ou récurrentes, d’un traitement antimicrobien inefficace et présentant soit une défaillance anticorps spécifique avérée (PSAF), soit un taux sérique d’IgG < 4 g/l. En outre, il est approuvé par l’EMA chez les adultes, les enfants et les adolescents (0-18 ans) atteints de polyneuropathie inflammatoire démyélinisante chronique (CIDP) en tant que traitement d’entretien après stabilisation par un traitement par immunoglobulines intraveineuses (IVIG). Aux États-Unis, HYQVIA est approuvé pour le traitement des adultes et des enfants âgés de deux ans et plus atteints de DIP, ainsi que comme traitement d’entretien chez les patients adultes atteints de CIDP. HYQVIA est administré par perfusion sous-cutanée dans le tissu adipeux sous-cutané et contient des IG issues du plasma humain. Les IG sont des anticorps qui maintiennent le système immunitaire de l’organisme. La composante hyaluronidase de HYQVIA facilite la dispersion et l’absorption des IG dans l’espace sous-cutané situé entre la peau et le muscle. HYQVIA est administré par perfusion jusqu’à une fois par mois (toutes les deux, trois ou quatre semaines pour la CIDP ; toutes les trois ou quatre semaines pour le PID). HyQvia® (immunoglobuline humaine normale) 100 mg/ml, solution pour perfusion à usage sous-cutané Informations importantes relatives à la sécurité (Union européenne) Veuillez consulter le résumé des caractéristiques du produit (RCP) de HyQvia (immunoglobuline humaine normale (SCIg)) avant de prescrire ce médicament, en particulier en ce qui concerne la posologie et la surveillance du traitement. CONSIGNES D’UTILISATION : le traitement doit être instauré et surveillé sous la supervision d’un médecin expérimenté dans le traitement de l’immunodéficience/du CIDP. Le médicament doit être administré par voie sous-cutanée (SC). La posologie et les schémas posologiques dépendent de l’indication. La posologie peut devoir être individualisée pour chaque patient en fonction de la pharmacocinétique et de la réponse clinique. La posologie basée sur le poids corporel peut nécessiter un ajustement chez les patients en insuffisance pondérale ou en surpoids. CONTRE-INDICATIONS : ne pas administrer par voie intraveineuse ou intramusculaire. Hypersensibilité à la substance active ou à l’un des excipients. Hypersensibilité aux immunoglobulines humaines, en particulier dans les cas très rares de déficit en IgA lorsque le patient présente des anticorps anti-IgA. Hypersensibilité systémique à l’hyaluronidase ou à la rHuPH20. POPULATIONS SPÉCIALES : Population pédiatrique : le schéma posologique pour les enfants et les adolescents (0 à 18 ans) dans le cadre des traitements de substitution et immunomodulateurs est le même que pour les adultes. Les mises en garde et précautions mentionnées dans le RCP s’appliquent aussi bien aux adultes qu’aux enfants. Grossesse : la sécurité d’emploi de ce médicament chez la femme enceinte n’a pas été établie dans le cadre d’études cliniques contrôlées ; il doit donc être administré avec prudence aux femmes enceintes et aux mères allaitantes. L’expérience clinique avec les immunoglobulines suggère qu’aucun effet nocif sur le déroulement de la grossesse ni sur le fœtus et le nouveau-né n’est à craindre. Fertilité : aucune donnée clinique de sécurité n’est actuellement disponible. L’expérience clinique acquise avec les immunoglobulines suggère qu’aucun effet néfaste sur la fertilité n’est à craindre. MISES EN GARDE ET PRÉCAUTIONS PARTICULIÈRES D’EMPLOI : Traçabilité : afin d’améliorer la traçabilité des médicaments biologiques, le nom et le numéro de lot du produit administré doivent être clairement consignés. Précautions d’emploi : si HyQvia est accidentellement administré dans un vaisseau sanguin, les patients pourraient développer un choc ; certaines réactions indésirables peuvent survenir plus fréquemment chez les patients recevant de l’immunoglobuline humaine normale pour la première fois ou, dans de rares cas, lors d’un changement de produit à base d’immunoglobuline humaine normale ou lorsqu’un long intervalle s’est écoulé depuis la perfusion précédente ; les complications potentielles peuvent souvent être évitées en perfusant initialement le produit lentement et en veillant à ce que les patients soient étroitement surveillés. Tous les autres patients doivent être surveillés pendant au moins 20 minutes après l’administration. Lorsque le traitement est administré à domicile, l’aide d’une autre personne responsable doit être disponible. Les patients suivant un traitement à domicile et/ou leur tuteur doivent également être formés à détecter les premiers signes d’hypersensibilité. En cas de réaction indésirable, il convient soit de réduire la vitesse d’administration, soit d’arrêter la perfusion. Aucune altération cutanée chronique n’a été observée lors des études cliniques. Il convient de rappeler aux patients de signaler toute inflammation chronique, tout nodule ou toute inflammation survenant au site de perfusion et persistant au-delà de quelques jours. Hypersensibilité à l’IG 10 % : les patients présentant des anticorps anti-IgA, pour lesquels le traitement par des produits à base d’IgS reste la seule option, ne doivent être traités par HyQvia que sous étroite surveillance médicale. Dans de rares cas, l’immunoglobuline humaine normale peut provoquer une chute de la pression artérielle accompagnée d’une réaction anaphylactique, même chez les patients ayant toléré un traitement antérieur par immunoglobuline humaine normale. Veuillez consulter le résumé des caractéristiques du produit (RCP) pour plus d’informations. Hypersensibilité au rHuPH20 : toute suspicion de réaction allergique ou de type anaphylactique après l’administration de rHuPH20 nécessite l’arrêt immédiat de la perfusion et l’administration d’un traitement médical standard, si nécessaire. Immunogénicité du rHuPH20 : le développement d’anticorps non neutralisants et d’anticorps neutralisants dirigés contre le composant rHuPH20 a été rapporté chez des patients recevant HyQvia dans le cadre d’études cliniques. Des événements thromboemboliques artériels et veineux ont été associés à l’utilisation d’immunoglobulines. Les patients doivent être suffisamment hydratés avant l’administration d’immunoglobulines. La prudence est de mise chez les patients présentant des facteurs de risque préexistants d’événements thromboemboliques. Surveillez les signes et symptômes de thrombose et évaluez la viscosité sanguine chez les patients à risque d’hyperviscosité. Une thrombose peut également survenir en l’absence de facteurs de risque connus. Les patients doivent être informés des premiers symptômes d’événements thromboemboliques et invités à contacter leur médecin immédiatement dès l’apparition d’un symptôme. Anémie hémolytique : les produits à base d’immunoglobulines contiennent des anticorps dirigés contre les groupes sanguins (par exemple A, B, D) qui peuvent agir comme des hémolysines. Les patients recevant des produits à base d’immunoglobulines doivent faire l’objet d’une surveillance visant à détecter les signes cliniques et les symptômes d’hémolyse. Syndrome de méningite aseptique (SMA) : des cas ont été rapportés en association avec un traitement par IgIV et IgSC ; les symptômes apparaissent généralement dans les heures ou les deux jours suivant le traitement par immunoglobulines. Les patients doivent être informés des premiers symptômes. L’arrêt du traitement par immunoglobulines peut entraîner une rémission du SMA en quelques jours sans séquelles. Le SMI peut survenir plus fréquemment en association avec un traitement par IgIV à forte dose (2 g/kg). Les données post-commercialisation n’ont pas mis en évidence de corrélation claire entre le SMI et des doses plus élevées. Une incidence plus élevée du SMI a été observée chez les femmes. Interférence avec les tests sérologiques : après perfusion d’immunoglobulines, l’augmentation transitoire des différents anticorps transférés passivement dans le sang du patient peut entraîner des résultats positifs trompeurs lors des tests sérologiques. Les perfusions de produits à base d’immunoglobulines peuvent entraîner des résultats faussement positifs dans les tests qui reposent sur la détection des ß-D-glucanes pour le diagnostic des infections fongiques. Agents transmissibles : les mesures standards visant à prévenir les infections résultant de l’utilisation de médicaments préparés à partir de sang ou de plasma humains comprennent la sélection des donneurs, le dépistage des dons individuels et des pools de plasma pour détecter des marqueurs spécifiques d’infection, ainsi que la mise en place d’étapes de fabrication efficaces pour l’inactivation/l’élimination des virus. Malgré cela, lorsque des médicaments préparés à partir de sang ou de plasma humain sont administrés, la possibilité de transmission d’agents infectieux ne peut être totalement exclue. Cela s’applique également aux virus inconnus ou émergents et à d’autres agents pathogènes. Les mesures prises sont considérées comme efficaces pour les virus enveloppés et non enveloppés. INTERACTIONS : vaccins à virus vivants atténués ; l’administration d’immunoglobulines peut altérer, pendant une période d’au moins 6 semaines et pouvant aller jusqu’à 3 mois, l’efficacité des vaccins à virus vivants atténués. Après l’administration de ce médicament, il convient d’attendre un délai de 3 mois avant de procéder à une vaccination par des vaccins à virus vivants atténués. Dans le cas de la rougeole, cette altération peut persister jusqu’à 1 an. Par conséquent, il convient de vérifier le statut immunitaire des patients recevant un vaccin contre la rougeole. EFFETS INDÉSIRABLES : les effets indésirables (EI) les plus fréquemment rapportés étaient des réactions locales. Les EI systémiques les plus fréquemment rapportés étaient les maux de tête, la fatigue, les nausées et la fièvre. La majorité de ces EI étaient légers à modérés. Des cas de méningite aseptique transitoire, de réactions hémolytiques transitoires, d’augmentation du taux de créatinine sérique et/ou d’insuffisance rénale aiguë ont été observés avec l’immunoglobuline humaine normale. Fréquence des effets indésirables par perfusion : très fréquents (≥ 1/10) : Réactions locales (au total, voir le RCP pour la liste détaillée des réactions locales) ; fréquents (≥ 1/100 à < 1/10) : céphalées, nausées, douleurs abdominales, douleurs abdominales basses, douleurs abdominales hautes et sensibilité abdominale, érythème, asthénie, fatigue, léthargie et malaise ; peu fréquents (≥ 1/1 000 à < 1/100) : vertiges, migraine, tremblements, paresthésie, tachycardie sinusale et tachycardie, augmentation de la pression artérielle et hypertension, diarrhée, vomissements, distension abdominale, prurit, éruption cutanée, éruption érythémateuse, éruption maculaire, éruption maculo-papuleuse et papule, urticaire, myalgie, arthralgie, gêne au niveau des membres et douleur aux extrémités, douleur dorsale, raideur articulaire, douleur thoracique d’origine musculo-squelettique, frissons, œdème, œdème périphérique et gonflement (systémique), œdème localisé, gonflement périphérique et œdème cutané, œdème gravitationnel, œdème génital, gonflement scrotal et gonflement vulvo-vaginal, sensation de brûlure ; rares (≥ 1/10 000 à < 1/1 000) : accident vasculaire cérébral et accident vasculaire cérébral ischémique, hypotension, dyspnée, douleur à l’aine, hémosidérinurie, hyperhidrose, test de Coombs direct positif et test de Coombs positif. Pour consulter le résumé des caractéristiques du produit de l’UE, rendez-vous sur : https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf Pour consulter les informations posologiques complètes aux États-Unis, rendez-vous sur : https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf À propos de Takeda Takeda se concentre sur la création d’une santé meilleure pour les gens et d’un avenir meilleur pour le monde. Notre objectif est de découvrir et de fournir des traitements qui transforment la vie dans nos principaux domaines thérapeutiques et commerciaux, y compris gastro-intestinal et inflammation, maladies rares, thérapies dérivées du plasma, oncologie, neurosciences et vaccins. En collaboration avec nos partenaires, nous visons à améliorer l’expérience des patients et à faire avancer un nouvel horizon d’options de traitement grâce à notre pipeline dynamique et diversifié. En tant que société biopharmaceutique basée sur des valeurs et axée sur la R&D, et dont le siège est au Japon, nous sommes guidés par notre engagement envers les patients, notre personnel et la planète. Nos employés dans environ 80 pays et régions sont motivés par notre raison d’être et ancrés dans les valeurs qui nous définissent depuis plus de deux siècles. Pour plus d’informations, rendez-vous sur www.takeda.com. Avis important Aux fins du présent avis, « communiqué de presse » désigne le présent document, toute présentation orale, toute séance de questions-réponses et tout document écrit ou oral discuté ou distribué par Takeda Pharmaceutical Company Limited (« Takeda ») concernant ce communiqué. Ce communiqué de presse (y compris tout exposé oral et toute question-réponse s’y rapportant) n’est pas destiné à, et ne constitue, ne représente ni ne fait partie d’aucune offre, invitation ou sollicitation d’aucune offre d’achat, autrement acquérir, souscrire, échanger, vendre ou autrement céder des titres ou solliciter un vote ou une approbation dans toute juridiction. Aucune action ou autre valeur mobilière n’est offerte au public par le biais de ce communiqué de presse. Aucune offre de valeurs mobilières ne sera faite aux États-Unis sans enregistrement en vertu du Securities Act américain de 1933, tel que modifié, ou sans exemption de celui-ci. Ce communiqué de presse est offert (ainsi que toute autre information qui pourrait être fournie au destinataire) à condition qu’il soit utilisé par le destinataire à des fins d’information uniquement (et non pour l’évaluation d’un investissement, d’une acquisition, d’une cession ou de toute autre opération). Tout manquement à ces restrictions pourrait constituer une violation des lois sur les valeurs mobilières applicables. Les sociétés dans lesquelles Takeda détient directement ou indirectement des investissements constituent des entités distinctes. Dans le présent communiqué de presse, le nom « Takeda » est parfois utilisé pour faire référence à Takeda et à ses filiales en général. De même, les termes « nous », « notre » et « nos » sont également utilisés pour désigner des filiales en général ou des personnes travaillant pour celles-ci. Ces expressions sont également utilisées lorsque l’identification de telle(s) société(s) ne sert aucun but utile. Déclarations prospectives Ce communiqué de presse et tout document distribué en relation avec celui-ci peuvent contenir des déclarations prospectives, des convictions ou des opinions concernant les activités futures de Takeda, sa position future et ses résultats d’exploitation, y compris des estimations, des prévisions, des objectifs et des plans pour Takeda. Sans s’y limiter, les déclarations prospectives incluent souvent des mots tels qu’« objectifs », « plans », « croit », « espère », « continue », « s’attend à », « vise à », « a l’intention de », « assure », « va », « peut », « devrait », « serait », « pourrait », « anticipe », « estime », « projette » ou des expressions similaires ou leur forme négative. Ces déclarations prospectives sont basées sur des hypothèses concernant de nombreux facteurs importants, y compris les suivants, qui pourraient faire en sorte que les résultats réels diffèrent sensiblement de ceux exprimés ou sous-entendus par les déclarations prospectives : circonstances économiques entourant les activités mondiales de Takeda, y compris les conditions économiques générales au Japon et aux États-Unis ; pressions et évolutions concurrentielles ; modifications des lois et réglementations applicables, y compris les réformes mondiales des soins de santé ; défis inhérents au développement de nouveaux produits, y compris l’incertitude du succès clinique et les décisions des autorités réglementaires et leur calendrier ; incertitude du succès commercial des produits nouveaux et existants ; difficultés ou retards de fabrication ; fluctuations des taux d’intérêt et des taux de change ; allégations ou préoccupations concernant l’innocuité ou l’efficacité des produits commercialisés ou des produits candidats ; impact des crises sanitaires, comme la nouvelle pandémie de coronavirus, sur Takeda et ses clients et fournisseurs, y compris les gouvernements étrangers dans les pays dans lesquels Takeda opère, ou sur d’autres facettes de son activité ; calendrier et impact des efforts d’intégration post-fusion avec les sociétés acquises ; capacité de céder des actifs qui ne sont pas essentiels aux opérations de Takeda et le calendrier de ces cessions ; et autres facteurs identifiés dans le dernier rapport annuel de Takeda sur formulaire 20-F et dans les autres rapports de Takeda déposés auprès de la U.S. Securities and Exchange Commission, disponibles sur le site Web de Takeda à l’adresse : https://www.takeda.com/investors/sec-filings-and-security-reports/ ou sur www.sec.gov. Takeda ne s’engage pas à mettre à jour les déclarations prospectives contenues dans ce communiqué de presse ou toute autre déclaration prospective qu’elle pourrait faire, sauf si la loi ou les règles boursières l’exigent. Les performances passées ne sont pas un indicateur des résultats futurs et les résultats ou déclarations de Takeda dans ce communiqué de presse peuvent ne pas être indicatifs et ne constituent pas une estimation, une prévision, une garantie ou une projection des résultats futurs de Takeda. Informations médicales Le présent communiqué de presse contient des informations relatives à des produits qui peuvent ne pas être disponibles dans tous les pays, ou peuvent l’être sous diverses marques commerciales, pour diverses indications et pour divers dosages ou doses. Aucune disposition des présentes ne doit être considérée comme une sollicitation, une promotion ou une publicité de quelque médicament sur ordonnance que ce soit, y compris ceux en cours de développement.   1 Immune Deficiency Foundation. Living With Primary Immunodeficiency. Consulté en avril 2026. Disponible sur : https://primaryimmune.org/living-primary-immunodeficiency. 2 Center for Disease Control and Prevention. About Primary Immunodeficiency (PI). Consulté en avril 2026. Disponible sur : https://www.cdc.gov/primary-immunodeficiency/about/index.html. 3 Immune Deficiency Foundation. Understanding Primary Immunodeficiency. Consulté en avril 2026. Disponible sur : https://primaryimmune.org/understanding-primary-immunodeficiency. 4 Kobrynski L, Powell RW, Bowen S. J Clin Immunol. 2014;34(8):954-961 Le texte du communiqué issu d’une traduction ne doit d’aucune manière être considéré comme officiel. La seule version du communiqué qui fasse foi est celle du communiqué dans sa langue d’origine. La traduction devra toujours être confrontée au texte source, qui fera jurisprudence. Consultez la version source sur businesswire.com : https://www.businesswire.com/news/home/20260504209344/fr/ Contact médias :
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media_relations@takeda.com Original: Takeda annonce les premiers résultats positifs d’un essai clinique pivot de phase 2/3 sur le TAK-881 dans le traitement des déficits immunitaires primaires (DIP)

Takeda gibt positive Topline-Ergebnisse einer entscheidenden klinischen Phase-2/3-Studie mit TAK-881 bei primären Immundefekten (PID) bekanntMay 5, 2026 8:39 PM
Business Wire Das Prüfpräparat TAK-881 war mit dem etablierten Medikament HYQVIA vergleichbar und zeigte gleichzeitig ein geringeres Infusionsvolumen und eine kürzere Infusionsdauer bei PID-Patienten Takeda ( TSE:4502/NYSE:TAK ) gab heute bekannt, dass TAK-881-3001, eine zulassungsrelevante klinische Phase-2/3-Studie bei Patienten mit primären Immundefekten (PID), ihren primären Endpunkt erreicht hat, der die pharmakokinetische (PK) Vergleichbarkeit zwischen dem Prüfpräparat TAK-881 [Immunglobulin subkutan (human), 20-prozentige Lösung (SCIG 20 %) mit rekombinanter humaner Hyaluronidase] und HYQVIA [Immunglobulin-Infusion (human) 10 % mit rekombinanter humaner Hyaluronidase] nachweisen konnte. Darüber hinaus zeigten die sekundären Endpunkte, dass TAK-881, ein mit Hyaluronidase versetztes SCIG 20 %, Sicherheits-, Wirksamkeits- und Verträglichkeitsprofile aufwies, die mit denen von HYQVIA, einem etablierten, mit Hyaluronidase versetzten SCIG 10 %, vergleichbar waren. Diese Ergebnisse untermauern das Potenzial von TAK-881, die erforderliche Immunglobulin-Dosis (IG) für PID-Patienten in der Hälfte des Volumens von HYQVIA zu verabreichen, wodurch die Infusionsdauer verkürzt wird, während gleichzeitig eine flexible Dosierung von bis zu einmal monatlich für Patienten beibehalten wird (alle drei oder vier Wochen bei PID). Die klinische Studie TAK-881-3001 untersuchte die Pharmakokinetik, Wirksamkeit, Sicherheit, Verträglichkeit und Immunogenität von TAK-881 bei Erwachsenen und pädiatrischen Patienten ab 2 Jahren mit PID, die zuvor mit einer IG-Therapie behandelt worden waren, und verglich diese mit HYQVIA bei Patienten ab 16 Jahren. Erste Topline-Daten zeigen, dass TAK-881: eine vergleichbare Pharmakokinetik erreichte: Die Studie erreichte ihren primären Endpunkt und zeigte eine gleichwertige Immunglobulin-G (IgG)-Exposition zwischen TAK-881 und HYQVIA, wie durch ein geometrisches Mittelverhältnis von 99,67% (90 % KI: 95,10 % bis 104,46 %) für die Flächen unter den Konzentrations-Zeit-Profilen über ein Dosierungsintervall im Steady State (AUC0-tau,ss) belegt. Immunschutz gewährleistet: TAK-881 zeigte vergleichbare Infektionsraten und einen vergleichbaren Immunschutz wie HYQVIA, wobei die schützenden IgG-Spiegel während der gesamten Studie konstant aufrechterhalten wurden. Nachweis eines vergleichbaren Sicherheitsprofils: Die Sicherheits- und Verträglichkeitsprofile von TAK-881 waren mit denen von HYQVIA vergleichbar, wobei keine neuen Sicherheitssignale beobachtet wurden. Das Sicherheitsprofil von TAK-881 wird in der laufenden Verlängerungsstudie TAK-881-3002 weiter evaluiert. „Diese Phase-2/3-Ergebnisse zeigten, dass das pharmakokinetische Profil von TAK-881 mit dem von HYQVIA vergleichbar war, einem etablierten IG-Standardtherapeutikum bei Patienten mit PID, während es gleichzeitig potenzielle Vorteile wie weniger Injektionsstellen, einen flexiblen Behandlungsplan und kürzere Infusionszeiten bietet“, sagte Dr. med. Kristina Allikmets, PhD, Senior Vice President und Leiterin der Forschung und Entwicklung für aus Plasma gewonnene Therapien bei Takeda. „TAK-881-3001 spiegelt unser umfassendes Engagement in Forschung und Entwicklung wider, IG-Therapien der nächsten Generation voranzutreiben und Patienten schneller sinnvolle neue Behandlungsoptionen anzubieten, während wir gleichzeitig die Auswahlmöglichkeiten für Patienten erweitern und strenge Standards hinsichtlich Wirksamkeit und Sicherheit einhalten.“ Für viele Patienten mit PID ist die IG-Ersatztherapie die einzige Behandlungsoption, um den Immunschutz gegen Infektionen aufrechtzuerhalten. Obwohl bestehende IG-Therapien wirksam sind, leiden viele Patienten weiterhin unter der Behandlungsbelastung, einschließlich häufiger oder großvolumiger Infusionen. „Patienten, die aufgrund einer PID eine lebenslange IG-Therapie benötigen, sind mit einer erheblichen Behandlungsbelastung konfrontiert. Eine Verbesserung des Verabreichungsprozesses kann diese Belastung verringern, indem sie das Behandlungserlebnis wesentlich verbessert“, sagte Dr. med. Richard L. Wasserman, PhD, Allergologe/Immunologe und Hauptprüfarzt für TAK-881-3001. „Diese Topline-Ergebnisse aus TAK-881-3001 sind ermutigend. Sie zeigen, dass ein hochkonzentriertes, durch Hyaluronidase vermittelter subkutaner IG-Ansatz Immunschutz bieten kann, verbunden mit einer besser zu bewältigenden Infusionserfahrung, die darauf abzielt, das tägliche Leben von Patienten mit PID zu verbessern.“ Die Analysen zu TAK-881-3001 dauern an, und Takeda geht davon aus, weitere Ergebnisse auf einem bevorstehenden medizinischen Forum vorzustellen. Takeda rechnet damit, im Geschäftsjahr 2026 Zulassungsanträge für TAK-881 bei den Zulassungsbehörden in den Vereinigten Staaten, der Europäischen Union und Japan einzureichen. Über TAK-881-3001 und TAK-881-3002 TAK-881-3001 war eine zulassungsrelevante klinische Phase-2/3-Studie zur Bewertung der Pharmakokinetik, Wirksamkeit, Sicherheit, Verträglichkeit und Immunogenität von TAK-881 bei Erwachsenen und pädiatrischen Patienten ab 2 Jahren mit primärer Immundefektur (PID), die zuvor mit einer Immunglobulintherapie (IG) behandelt worden waren. Studienteilnehmer im Alter von 16 Jahren und älter wurden randomisiert und erhielten im offenen, randomisierten Crossover-Teil der Studie bis zu 51 Wochen lang entweder TAK-881 gefolgt von HYQVIA oder HYQVIA gefolgt von TAK-881 in derselben Dosis und mit demselben Dosierungsintervall wie bei IG. Teilnehmer im Alter von 2 bis < 16 Jahren wurden im offenen, einarmigen Studienteil bis zu 27 Wochen lang ausschließlich mit TAK-881 behandelt. Weitere Informationen zur klinischen Studie TAK-881-3001 sind auf ClinicalTrials.gov unter der Studien-ID NCT05755035 verfügbar. TAK-881-3002 ist eine Phase-3-Studie zur Bewertung der langfristigen Sicherheit und Verträglichkeit von TAK-881 bei Patienten mit PID und stellt die Verlängerungsstudie von TAK-881-3001 dar. Weitere Informationen zur klinischen Studie TAK-881-3002 sind auf ClinicalTrials.gov unter der Studien-ID NCT06076642 verfügbar. Über TAK-881 TAK-881 [Immunglobulin subkutan (human), 20 %ige Lösung (SCIG 20 %) und rekombinante humane Hyaluronidase] ist ein flüssiges Prüfpräparat, bestehend aus einer Ampulle Immunglobulin (IG) 20 % und einer Ampulle der rekombinanten humanen Hyaluronidase von Halozyme (rHuPH20). IG wird aus menschlichem Plasma gewonnen und unterstützt das körpereigene Immunsystem. TAK-881 wird unter die Haut in das subkutane Fettgewebe infundiert, wo die Hyaluronidase die Verteilung erleichtert und die Absorption des Immunglobulins im subkutanen Gewebe erhöht, wodurch größere Volumina an einer bestimmten Infusionsstelle verabreicht werden können. Als durch Hyaluronidase unterstütztes SCIG 20 % wird TAK-881 mit dem Ziel entwickelt, das Infusionsvolumen und die Infusionsdauer zu reduzieren und gleichzeitig Patienten mit PID einen wirksamen Immunschutz zu bieten. Über primäre Immundefekte (PID) Primäre Immundefekte (PID) sind eine Gruppe von mehr als 550 seltenen und chronischen Erkrankungen, bei denen ein Teil des körpereigenen Immunsystems fehlt oder nicht ordnungsgemäß funktioniert.1 Diese Erkrankungen resultieren aus genetischen Mutationen, die in der Regel vererbt werden.2 Die Symptome von PID variieren und können häufige und/oder anhaltende Infektionen sowie ungewöhnliche Autoimmunreaktionen umfassen, was oft zu langen Phasen der Fehldiagnose führt, trotz Konsultationen bei mehreren Spezialisten.3 In den Vereinigten Staaten ist etwa 1 von 1.200 Menschen von PID betroffen.4 Über HYQVIA® HYQVIA® [Immunglobulin-Infusion 10 % (human) mit rekombinanter humaner Hyaluronidase] ist ein flüssiges Arzneimittel, das 10 % Immunglobulin (IG) und die rekombinante humane Hyaluronidase (rHuPH20) von Halozyme enthält. HYQVIA ist von der Europäischen Arzneimittelagentur (EMA) als Ersatztherapie bei Erwachsenen, Kindern und Jugendlichen (0–18 Jahre) mit primärem Immundefekt (PID) mit beeinträchtigtem Antikörperschutz sowie bei Patienten mit sekundärem Immundefekt (SID) zugelassen, die an schweren oder wiederkehrenden Infektionen, einer unwirksamen antimikrobiellen Behandlung und entweder einem nachgewiesenen spezifischen Antikörperversagen (PSAF) oder einem Serum-IgG-Spiegel von

1?1?????????????????????????????????????????????????????????????????????????????March 28, 2026 3:00 PM
Business Wire

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The topline results of these studies were disclosed on December 18, 2025 in, “Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment”.



Gooderham M, et al. Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002). Presented at American Academy of Dermatology 2026. 2026 Mar 28; Denver, CO.



Dhabale A, Nagpure S. Types of psoriasis and their effects on the immune system. Cureus. 2022 Sep 24;14(9):e29536. doi: 10.7759/cureus.29536.



Gkini MA, Nakamura M, Alexis AF, et al. Psoriasis in People With Skin of Color: An Evidence-Based Update. Int J Dermatol. 2025;64(4):667-677. doi:10.1111/ijd.17651



Taliercio VL, Snyder AM, Webber LB, et al. The Disruptiveness of Itchiness from Psoriasis: A Qualitative Study of the Impact of a Single Symptom on Quality of Life. J Clin Aesthet Dermatol. 2021;14(6):42-48.



Snyder AM, Taliercio VL, Webber LB, et al. The Role of Pain in the Lives of Patients with Psoriasis: A Qualitative Study on an Inadequately Addressed Symptom. J Psoriasis Psoriatic Arthritis. 2022;7(1):29-34. doi:10.1177/24755303211066928



Dopytalska K, Sobolewski P, Blaszczak A, Szymanska E, Walecka I. Psoriasis in Special Localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718.



Blackstone B, Patel R, Bewley A. Assessing and Improving Psychological Well-Being in Psoriasis: Considerations for the Clinician. Psoriasis (Auckl). 2022;12:25-33.doi:10.2147/PTT.S328447.



AIQassimi S, AIBrashdi S, Galadari H, Hashim MJ. Global Burden of Psoriasis - Comparison of Regional and Global Epidemiology, 1990 to 2017. Int J Dermatol. 2020;59(5):566-571. doi: 10.llll/ijd.14864.



Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025. https://www.ncbi.nlm.nih.gov/books/NBK430879/.



Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective and Potent Allosteric TYK2 Inhibitor. May 26, 2025. J Invest Dermatol. 2025 May 27:S0022-202X(25)00531-7. doi:10.1016/j.jid.2025.05.014.



Shang L, et al. TYK2 in immune responses and treatment of psoriasis. J Inflamm Res. 2022;15:5373-5385. 2022 Sep 16. doi:10.2147/JIR.S380686



Leit S, Greenwood J, Carriero S, et al. Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279. J Medicinal Chemistry.2023;66(15):10473-10496.doi.org/10.1021/acs.jmedchem.3c00600.



A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis. ClinicalTrials.gov Identified: NCT06973291. Updated December 17, 2025. Accessed March 2026.https://clinicaltrials.gov/study/NCT06973291.



Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated March 9, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT06671483.



A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated March 9, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT06671496.



A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov Identifier: NCT06233461. Updated February 11, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT06233461.



A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov Identifier: NCT06254950. Updated March 13, 2026. Accessed March 2026. https://www.clinicaltrials.gov/study/NCT06254950.



A Study of Zasocitinib in Adults With Nonsegmental Vitiligo. ClinicalTrials.gov Identifier: NCT07108283. Updated March 13, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT07108283.



A Takeda Presentation. Quarterly Results - Quarter 1 FY2025. Available at: https://assets-dam.takeda.com/image/upload/v1753839858/Global/Investor/Financial-Results/FY2025/Q1/qr2025_q1_p01_en.pdf. Accessed March 2026.



A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-Severe Plaque Psoriasis During 52 Weeks of Treatment. ClinicalTrials.gov Identifier: NCT06088043. Updated October 24, 2025. Accessed March 2026. https://clinicaltrials.gov/study/NCT06088043.



A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period. ClinicalTrials.gov Identifier: NCT06108544. Updated November 11, 2025. Accessed March 2026. https://clinicaltrials.gov/study/NCT06108544.



Muromoto R, Oritani K, Matsuda T. Current Understanding of the Role of Tyrosine Kinase 2 Signaling in Immune Responses. World J Biol Chem. 2022;13(1):1–14. doi:10.4331/wjbc.v13.i1.1.



Danese S, Peyrin-Biroulet L. Selective Tyrosine Kinase 2 Inhibition for Treatment of Inflammatory Bowel Disease: New Hope on the Rise. Inflamm Bowel Dis. 2021;27(12):2023-2030. doi: 10.1093/ibd/izab135.



Rusiñol L, Puig L. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases. Int J Mol Sci. 2023;24(4):3391. Published 2023 Feb 8. doi:10.3390/ijms24043391.



Krueger JG, McInnes IB, Blauvelt A. Tyrosine Kinase 2 and Janus Kinase?Signal Transducer and Activator of Transcription Signaling and Inhibition in Plaque Psoriasis. J Am Acad Dermatol. 2022;86(1):148-157. doi:10.1016/j.jaad.2021.06.869.


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Alan Walshe Appointed General Manager of Takeda CanadaMarch 2, 2026 7:59 AM
PR Newswire (Canada)

A proven people-focused commercial strategist with extensive global experience to lead Takeda Canada's next chapter of growth and impact.TORONTO, March 2, 2026  /CNW/ - Takeda Canada Inc. ("Takeda Canada") is pleased to announce the appointment of Alan Walshe as General Manager for Canada.







Alan brings 17 years of experience with Takeda and its predecessor companies, most recently serving as Global Head of Commercial Strategy for the Plasma-Derived Therapies Business Unit."Alan's depth of commercial expertise and global perspective, combined with his people-focused leadership style and long-standing commitment to Takeda's mission, make him an outstanding choice to lead our Canadian business and further strengthen our presence in this critical market," said Jean-Luc Delay, President of the Europe and Canada Business Unit at Takeda. "I am confident that under Alan's leadership, we will further advance access to innovative medicines and deliver transformative impact for patients across Canada."As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, Takeda is focused on bringing better health and a brighter future to people around the world. Operating in Canada since 2009, 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."I am honoured to step into the role of General Manager for Takeda in Canada and to join such a dedicated and talented team, said Alan Walshe. "I am deeply confident in our ability to accelerate Takeda's impact here. Canada is one of Takeda's most important and dynamic markets, and I look forward to building on our strong foundation as we expand access to innovative therapies, strengthen partnerships, and advance meaningful outcomes for patients and communities nationwide."Alan holds Master Degrees in Biotechnology (Immunology & Genetics) from University College Dublin (UCD), and in Management from UCD Michael Smurfit Graduate Business School.About Takeda Canada Inc.Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK).  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: https://www.takeda.com/en-ca/SOURCE Takeda Canada Inc.

Original: Alan Walshe Appointed General Manager of Takeda Canada

Alan Walshe est nommé directeur général de Takeda CanadaMarch 2, 2026 7:59 AM
PR Newswire (Canada)

Un stratège commercial reconnu, axé sur les personnes et possédant une vaste expérience à l'échelle mondiale, sera responsable du prochain chapitre de la croissance et de l'influence de Takeda Canada.TORONTO, le 2 mars 2026 /CNW/ - Takeda Canada Inc. (« Takeda Canada ») est heureuse d'annoncer la nomination d'Alan Walshe au poste de directeur général pour le Canada.







Alan possède 17 ans d'expérience au sein de Takeda et des entreprises qui l'ont précédée où plus récemment, il a occupé le poste de directeur mondial de la stratégie commerciale, unité d'affaires Thérapies à base de plasma.« L'expertise commerciale et la perspective mondiale approfondies d'Alan, combinées à son style de leadership axé sur les personnes et à son engagement de longue date à l'égard de la mission de Takeda, font de lui un choix exceptionnel pour diriger nos activités canadiennes et renforcer davantage notre présence dans ce marché critique », a déclaré Jean-Luc Delay, président de l'unité d'affaires, Europe et Canada de Takeda. « Je suis convaincu que, sous la direction d'Alan, nous ferons progresser encore plus l'accès à des médicaments novateurs et que nous aurons un effet transformateur pour les patients partout au Canada. »Figurant parmi les plus grandes entreprises biopharmaceutiques axées sur les valeurs, Takeda, dont le siège social est au Japon, s'efforce d'offrir une santé meilleure et un avenir prometteur aux gens du monde entier. Nous exerçons nos activités au Canada depuis 2009 et avons pour but de découvrir et d'offrir des traitements qui transforment la vie dans nos principaux domaines thérapeutiques et commerciaux, y compris les maladies gastro-intestinales et inflammatoires, les maladies rares, les thérapies à base de plasma, l'oncologie, les neurosciences et les vaccins.« C'est un honneur pour moi d'occuper le poste de directeur général de Takeda au Canada et de me joindre à une équipe aussi dévouée et talentueuse, a déclaré Alan Walshe. Je suis profondément convaincu de notre capacité à accélérer l'influence de Takeda ici. Le Canada est l'un des marchés les plus importants et dynamiques de Takeda, et je me réjouis à l'idée de tirer parti de nos bases solides tandis que nous élargissons l'accès à des traitements novateurs, renforçons les partenariats et faisons progresser des résultats concrets pour les patients et les communautés à l'échelle nationale. »Alan est titulaire d'une maîtrise en biotechnologie (immunologie et génétique) de l'University College de Dublin (UCD) et d'une maîtrise en gestion de la Michael Smurfit Graduate Business School de l'UCD.À propos de Takeda Canada Inc.Takeda Canada Inc. est la filiale canadienne de Takeda Pharmaceutical Company Limited (TSE : 4502/NYSE : TAK). Takeda se concentre sur la création d'une meilleure santé pour la population et d'un avenir meilleur pour le monde. Nous visons à découvrir et à offrir des traitements qui transforment la vie dans nos principaux domaines thérapeutiques et commerciaux, y compris les maladies gastro-intestinales et inflammatoires, les maladies rares, les thérapies à base de plasma, l'oncologie, les neurosciences et les vaccins. Avec nos partenaires, nous cherchons à améliorer l'expérience des patients et à repousser les limites des nouvelles options thérapeutiques grâce à notre gamme de produits en développement dynamique et diversifiée. En tant qu'entreprise biopharmaceutique axée sur les valeurs et la recherche et développement, dont le siège social se trouve au Japon, nous sommes guidés par notre engagement envers les patients, notre population et la planète. Nos employés dans environ 80 pays et régions sont motivés par notre raison d'être et enracinés dans les valeurs qui nous définissent depuis plus de deux siècles. Pour de plus amples renseignements, visitez le site https://www.takeda.com/fr-ca/SOURCE Takeda Canada Inc.

Original: Alan Walshe est nommé directeur général de Takeda Canada

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1February 10, 2026 3:15 AM
Business Wire

This FDA Acceptance is a Milestone for People Living with Narcolepsy Type 1 Who Need New and Different Treatment Options



Oveporexton is an Orexin Agonist Designed to Restore Orexin Signaling and Address the Underlying Orexin Deficiency that Causes Narcolepsy Type 1



The Prescription Drug User Fee Act (PDUFA) Target Action Date is the Third Quarter of this Calendar Year



Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. Takeda remains on track to potentially bring the first approved orexin agonist treatment to people living with NT1.


NT1 is a chronic, rare neurological disease caused by a loss of orexin and characterized by excessive daytime sleepiness and cataplexy (sudden loss of muscle tone). This results in a spectrum of physical, cognitive and psychosocial effects that can have a debilitating impact on many aspects of a person’s life, including work, education and social interactions. Despite existing therapies, the majority of patients continue to experience symptoms and are forced to cope with the continued impact of NT1.


“The FDA’s acceptance of our NDA is a milestone for people living with narcolepsy type 1,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Considering the high unmet need, this community deserves a new and different treatment approach that aims to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. We are one step closer to potentially transforming the current treatment paradigm and intend to deliver through our leading work in orexin science.”


The NDA filing is supported by a comprehensive data package including the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) global Phase 3 studies. Key oveporexton data measuring objective and patient-reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common adverse events were insomnia, urinary urgency and urinary frequency. Learn more about the Phase 3 data results here.


Oveporexton previously received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in NT1 from the U.S. FDA and the Center for Drug Evaluation of China’s National Medical Products Administration. Oveporexton has also received Sakigake designation from the Japanese Ministry of Health, Labour and Welfare.


The NDA filing has no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026.


About Takeda’s Orexin Franchise


Takeda is spearheading orexin science with the most advanced development program. The tailored portfolio of investigational orexin agonists could benefit a broad range of conditions where orexin biology plays a role. Oveporexton is the lead investigational orexin receptor 2 (OX2R)-selective agonist asset in Takeda’s orexin franchise, currently in late-stage development for the treatment of NT1. TAK-360 is the next oral OX2R agonist in Takeda’s orexin franchise, initially being developed for individuals with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Additional orexin agonists are also in development, including TAK-495.


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 www.takeda.com.


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 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. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.


The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.


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: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. 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.


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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260210380286/en/
Japanese Media:

Tsuyoshi Tada

tsuyoshi.tada@takeda.com


U.S. and International Media:

Cassie Ercanbrack

cassie.ercanbrack@takeda.com


Original: U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

Takeda Reports Third-Quarter FY2025 Results: Updates Full Year Outlook to Reflect VYVANSE® Generics Impact, OPEX Discipline and FX Tailwind; Progressing Toward Three Transformative Launches AheadJanuary 29, 2026 1:37 AM
Business Wire

Year-to-Date Revenue Declined by 2.8% at Constant Exchange Rate (CER), 3.3% at Actual Exchange Rates (AER); Impact of VYVANSE® Generics is Tapering Off



Core Operating Profit Declined by 3.4% at both CER and AER Year to Date



Reported Operating Profit Increased by 1.2% at AER Year to Date, Lower Restructuring Expenses More Than Offset Impairment



 


Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the third quarter of fiscal year 2025 (nine months ended December 31, 2025). The gap between incremental Growth & Launch Products revenue and VYVANSE erosion is narrowing, and operational efficiencies drove year-on-year reductions in operating expenses, including R&D. The company raised its full-year forecasts based on cost discipline and FX tailwind, while its Revenue Management Guidance has been updated primarily due to the impact of VYVANSE generics.


Takeda is positioned for long-term growth and has multiple late-stage programs with multibillion-dollar peak revenue potential. Following the positive readouts from Phase 3 studies in 2025, the company has submitted New Drug Applications (NDAs) for oveporexton and rusfertide and is on track to file an NDA for zasocitinib. Each of these programs, which Takeda expects to launch within the next 18 months, has the potential to redefine standards of care, transform patient lives and contribute to Takeda's new growth trajectory.


Takeda chief financial officer, Milano Furuta, commented:

“While we manage the impact of VYVANSE generics, we are implementing disciplined cost management and improving operational efficiency and therefore expect to achieve the previously disclosed Management Guidance for Core Operating Profit.


“FY2025 remains a truly pivotal year for Takeda as we are in a phase of preparing for significant new product launches. Looking ahead, with multiple innovative launches and a robust late-stage pipeline, Takeda is positioned to bring life-transforming medicines that improve patient lives and deliver long-term shareholder value.”


FINANCIAL HIGHLIGHTS for FY2025 Q3 YTD Ended December 31, 2025




(Billion yen, except percentages and per share amounts)





 



Item






FY2025 Q3 YTD






FY2024 Q3 YTD






vs. PRIOR YEAR




(Actual % change)





 



Revenue






3,411.2






3,528.2






-3.3%





 



Operating Profit






422.4






417.5






+1.2%





 



Net Profit






216.1






211.1






+2.4%





 



EPS (Yen)






137






134






+2.7%





 



Operating Cash Flow






966.9






835.0






+15.8%





 



Adjusted Free Cash Flow (Non-IFRS)






625.9






568.3






+10.1%





 




Core (Non-IFRS)








(Billion yen, except percentages and per share amounts)








Item






FY2025 Q3 YTD






FY2024 Q3 YTD






vs. PRIOR YEAR




(Actual % change)






vs. PRIOR YEAR




(CER % change)








Revenue






3,411.2






3,528.2






-3.3%






-2.8%








Operating Profit






971.6






1,006.3






-3.4%






-3.4%








Margin






28.5%






28.5%






-0.0 pp






?








Net Profit






673.6






698.9






-3.6%






-3.4%








EPS (Yen)






428






443






-3.3%






-3.1%









FY2025 Outlook








Updating Full Year Management Guidance for Revenue and Forecasts








Takeda has updated its full year Management Guidance for Revenue primarily due to VYVANSE and raised full year forecasts to reflect cost discipline and FX tailwind.







 



FY2025 Management Guidance Core Change at CER (Non-IFRS)








Item






FY2025 PREVIOUS MANAGEMENT GUIDANCE

(October 2025)






FY2025 REVISED MANAGEMENT GUIDANCE

(January 2026)








Core Revenue






Broadly flat






Low-single-digit % decline








Core Operating Profit






Low-single-digit % decline






Low-single-digit % decline








Core EPS






Low-single-digit % decline






Low-single-digit % decline









FY2025 Reported and Core Forecasts








(Billion yen, except percentages and per share amounts)








Item






FY2025

PREVIOUS FORECAST




(October 2025)






FY2025




REVISED FORECAST




(January 2026)








Revenue






4,500.0






4,530.0








Core Revenue (Non-IFRS)






4,500.0






4,530.0








Operating Profit






400.0






410.0








Core Operating Profit (Non-IFRS)






1,130.0






1,150.0








Net Profit






153.0






154.0








EPS (Yen)






97






98








Core EPS (Yen) (Non-IFRS)






479






486








Adjusted Free Cash Flow (Non-IFRS)






600.0-700.0






650.0-750.0








Annual Dividend per Share (Yen)






200






200







Additional Information About Takeda’s FY2025 Q3 Results

For more details about Takeda’s FY2025 Q3 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 Q3 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/).


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 www.takeda.com.


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. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.


The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. 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: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. 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 FY2025 Q3 investor presentation (available at www.takeda.com/investors).


Peak Revenue Potential and PTRS Estimates

References in this press release to peak revenue ranges are estimates that have not been adjusted for probability of technical and regulatory success (PTRS) and should not be considered a forecast or target. These peak revenue ranges represent Takeda’s assessments of various possible future commercial scenarios that may or may not occur. References in this press release to PTRS are to internal estimates of Takeda regarding the likelihood of obtaining regulatory approval for a particular product in a particular indication. These estimates reflect the subjective judgment of responsible Takeda personnel and have been approved by Takeda’s Portfolio Review Committee for use in internal planning.


U.S. Dollar Convenience Translations

In this press release, certain amounts presented in Japanese yen have been translated to U.S. dollars solely for the convenience of the reader. Except where otherwise noted, these convenience translations have been made at an exchange rate of 1USD = 156.80 JPY, the Noon Buying Rate certified by the Federal Reserve Bank of New York on December 31, 2025. The rate and methodologies used for these convenience translations differ from the currency exchange rates and translation methodologies under IFRS used for the preparation of Takeda’s consolidated financial statements. These translations should not be construed as a representation that the Japanese yen amounts could be converted into U.S. dollars at this or any other rate.


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.


Please refer to slide 7 of Takeda’s FY2025 Q3 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/) for the definition of Growth & Launch Products.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260128993781/en/
Investor Relations

Christopher O’Reilly

Christopher.oreilly@takeda.com

+81 (0) 90-6481-3412
Media Relations

Media_Relations@takeda.com


Original: Takeda Reports Third-Quarter FY2025 Results: Updates Full Year Outlook to Reflect VYVANSE® Generics Impact, OPEX Discipline and FX Tailwind; Progressing Toward Three Transformative Launches Ahead

🌿 Cancer-Related Nausea & Appetite Loss
Cannabis: THC and CBD are used to reduce chemotherapy-induced nausea and stimulate appetite naturally.

Pharma/Biotech: Synthetic antiemetics (like ondansetron) and lab-made appetite stimulants dominate the market.

Competition: Cannabis is seen as a plant-based comfort option, while pharma emphasizes precision drugs with FDA approval. $TAK $TLRY $CGC $MSOS

TAK under. $16

TAK over $10

Just saying,

https://www.takeda.com/newsroom/newsreleases/2022/takedas-biologics-license-application-bla-for-dengue-vaccine-candidate-tak-003-granted-priority-review-by-us-food-and-drug-administration

4 months or less until an answer. Expedited review is six months or less now. It was accepted Nov 22nd.

Big if we get FDA apprvoval. ETF's in the know are sucking up shares.

Other approved drug has serious side effects vs. ours.

300M cases a year from mosquito bites.

Boing X 2

Takeda’s Pipeline Has Potential to Contribute Significantly to Revenue Growth Over Next Decade

https://www.businesswire.com/news/home/20201208005955/en/Takeda%E2%80%99s-Pipeline-Has-Potential-to-Contribute-Significantly-to-Revenue-Growth-Over-Next-Decade

Japan's Takeda eyes new focus on vaccines after OTC asset sales - CEO

https://www.reuters.com/article/health-coronavirus-takeda-vaccines-idUSKBN27M0F7

MIT-Takeda program launches

Research projects will harness the power of artificial intelligence to positively impact human health.

https://news.mit.edu/2020/mit-takeda-program-launches-research-ai-and-human-health-0618

Takeda shares tumbled as much as 9.3 percent in early trading in Tokyo on Wednesday. The Japanese company is offering the equivalent of 49 pounds ($68.55) per share, including 27.26 pounds in stock and 21.75 pounds in cash, Shire said in a statement. That’s a 60 percent premium to Shire’s closing share price on March 27, before Takeda disclosed it was interested in the US drug maker.

ADR is 3:1 - NICE!
60 percent upside
Added 36.83 US stock
Added 29.38 US cash


Not a bad deal!

So how does the Shire shareholder make out on this deal?

Takeda shares tumbled as much as 9.3 percent in early trading in Tokyo on Wednesday. The Japanese company is offering the equivalent of 49 pounds ($68.55) per share, including 27.26 pounds in stock and 21.75 pounds in cash, Shire said in a statement. That’s a 60 percent premium to Shire’s closing share price on March 27, before Takeda disclosed it was interested in the US drug maker.

Where is the 60percent premium to Close of March 27 2018 at shire 128.87

Takeda article: enGene Shines with a Host of Big Name Collaborations

http://marketexclusive.com/engene-shines-with-a-host-of-big-name-collaborations/1281/