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Takeda Pharmaceutical Company reported that the U.S. FDA has accepted the New Drug Application and granted Priority Review for rusfertide, an investigational first-in-class hepcidin mimetic peptide for adults with polycythemia vera. The agency set a Prescription Drug User Fee Act target action date in the third quarter of this calendar year.
The NDA is primarily supported by the Phase 3 VERIFY study, where rusfertide plus standard of care more than doubled clinical response rates versus standard care alone, as well as four-year efficacy and safety data from Phase 2 REVIVE/THRIVE studies. Rusfertide met its primary and all four key secondary endpoints and was generally well-tolerated, with injection site reactions, anemia and fatigue as the most common adverse events.
Rusfertide has also received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA. Takeda states that the impact of the NDA acceptance on its financial results for the fiscal year ending March 31, 2026 is immaterial.
Takeda Pharmaceutical Company Limited filed a Form 6-K highlighting that the U.S. Food and Drug Administration has accepted its New Drug Application and granted Priority Review for oveporexton (TAK-861) to treat narcolepsy type 1, a rare neurological disease driven by orexin loss. Oveporexton is an investigational oral orexin receptor 2-selective agonist designed to restore orexin signaling and address the underlying orexin deficiency that causes narcolepsy type 1.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year, positioning oveporexton as a potential first-in-class orexin agonist therapy. The application is supported by global Phase 3 FirstLight and RadiantLight studies that showed statistically significant, clinically meaningful improvements across key symptoms and quality-of-life measures, with a generally well-tolerated safety profile. Takeda states that this NDA filing has no significant impact on its full year consolidated forecast for the fiscal year ending March 31, 2026.
Takeda Pharmaceutical Company Limited reported mixed results for the nine months ended December 31, 2025. Revenue fell to JPY 3,411.2 billion, down 3.3% year over year, mainly because its ADHD drug VYVANSE in the U.S. faced heavy generic competition, sharply reducing Neuroscience revenue.
Despite lower sales, cost controls and fewer restructuring charges helped operating profit edge up 1.2% to JPY 422.4 billion, while net profit rose 2.4% to JPY 216.3 billion. Core operating profit and Core EPS declined about 3–4% as Takeda absorbed lower Neuroscience revenue and higher impairments on certain R&D assets.
The balance sheet strengthened, with total assets at JPY 15.4 trillion and the equity ratio improving to 49.6%. Operating cash flow increased to JPY 966.9 billion, supporting ongoing dividends; the company projects a full-year dividend of JPY 200 per share. Management slightly raised FY2025 revenue, operating profit and EPS forecasts, mainly from foreign-exchange tailwinds, but revised Core Revenue guidance to a low-single-digit decline at constant exchange rates.
Takeda reported strong Phase 3 results for its investigational oral psoriasis drug zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis. Two large, randomized, double-blind studies showed zasocitinib was superior to placebo at week 16 on both co-primary goals: static Physician Global Assessment (sPGA 0/1) and Psoriasis Area and Severity Index (PASI 75). All 44 ranked secondary endpoints, including higher bars of PASI 90 and PASI 100 against both placebo and apremilast, were also met.
More than half of treated patients achieved clear or almost clear skin (PASI 90), and on average about 30 percent reached completely clear skin (PASI 100) by week 16, with responses continuing to improve through week 24. Zasocitinib was generally well-tolerated, with common side effects such as upper respiratory infections, nasopharyngitis and acne, and no new safety signals. Takeda plans to submit a New Drug Application to the U.S. Food and Drug Administration and other regulators starting in fiscal year 2026, and currently expects these results to have no significant impact on its full-year forecast for the fiscal year ending March 31, 2026.
Takeda Pharmaceutical Company Limited shareholder plans to sell American Depositary Shares under Rule 144. The notice covers the proposed sale of 29,619 ADSs through Interactive Brokers LLC on the NYSE, with an aggregate market value of $421,182.18. The filing states that 123,490,548 ADSs were outstanding at the time of the notice. The ADSs to be sold were acquired as vested restricted stock unit awards from Takeda on three dates, with 20,046 ADSs acquired on July 1, 2023, 13,592 ADSs on July 1, 2022, and 5,858 ADSs on July 1, 2021, each described as compensation.
Takeda Pharmaceutical Company Limited filed a Form 6-K highlighting new longer-term clinical data for rusfertide, a Phase 3 investigational treatment for polycythemia vera developed with Protagonist Therapeutics. At 52 weeks in the pivotal VERIFY study, 61.9% of patients continuously treated with rusfertide plus standard care maintained a durable clinical response, defined by absence of phlebotomy eligibility, and mean hematocrit stayed below 43%, supporting sustained blood count control. Patients who switched from placebo to rusfertide at Week 32 also showed strong responses, with 77.9% achieving absence of phlebotomy eligibility between Weeks 40 and 52. Long-term THRIVE extension data in 46 patients showed a more than 13-fold reduction in annual therapeutic phlebotomy rate, from 9.2 to 0.7 phlebotomies per year, with a safety profile generally consistent with earlier studies and no new signals. Takeda states that the impact of these study results on its financial performance for the fiscal year ending March 31, 2026 is immaterial.
Takeda Pharmaceutical Company Limited has an affiliated holder filing a notice to sell American Depositary Shares (ADSs) under Rule 144. The planned sale covers 87,023 ADSs with an aggregate market value of $1,242,688.44, to be executed through Interactive Brokers LLC on the NYSE, with an approximate sale date of 12/05/2025. The table notes that 123,490,548 ADSs are outstanding.
The securities to be sold were acquired as compensation through vested restricted stock unit (RSU) awards from Takeda on three dates: 99,692 ADSs on 07/01/2023, 31,896 ADSs on 07/01/2022, and 17,200 ADSs on 07/01/2021. By signing the notice, the selling person represents that they are not aware of any material adverse, nonpublic information about Takeda’s current or prospective operations.
Takeda Pharmaceutical Company Limited (TAK) insider has filed a notice to sell American Depositary Shares. The filing covers the planned sale of 58,421 ADSs through Interactive Brokers LLC on the NYSE, with an indicated aggregate market value of $836,004.51. The filing notes that 123,490,548 ADSs were outstanding at the time of the notice, providing context for the size of the intended sale.
The seller previously acquired 81,862 ADSs on 07/01/2023 through vested restricted stock unit awards from Takeda Pharmaceutical Company Limited, characterized as compensation. The individual also represents that they are not aware of any undisclosed material adverse information about the issuer’s current or prospective operations.
Takeda Pharmaceutical Co Ltd filed a Form 13F reporting institutional holdings through its reporting manager. The filing lists 9 holdings with a total reported market value of $16,369,175 and names one other included manager, Takeda Vaccines, Inc. The signature is dated 11-13-2025.