Welcome to our dedicated page for Takeda Pharm news (Ticker: TAK), a resource for investors and traders seeking the latest updates and insights on Takeda Pharm stock.
Takeda Pharmaceutical Company Limited reports news as a Japan-based, R&D-driven biopharmaceutical company whose American depositary shares trade under TAK. Its updates center on medicines and pipeline programs in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, including ENTYVIO, GAMMAGARD LIQUID ERC, HYQVIA, TAK-881, zasocitinib, rusfertide and oveporexton.
Recurring developments include pivotal clinical trial data, U.S. FDA regulatory actions involving new drug applications, prescription product availability, collaboration updates, and financial reports. Takeda also reports on launch preparation, generic competition affecting established products, operating-cost discipline, foreign-exchange effects, corporate transformation initiatives and governance matters tied to its global pharmaceutical business.
Summary not available.
Takeda (NYSE:TAK) reported positive topline results from the pivotal Phase 2/3 TAK-881-3001 trial in primary immunodeficiency disease (PID).
The study met its primary endpoint showing PK comparability to HYQVIA with a geometric mean ratio of 99.67% (90% CI: 95.10%–104.46%) for AUC0-tau,ss. TAK-881 maintained protective IgG levels, showed comparable infection rates and safety, and delivered required doses at about half the infusion volume with shorter infusion duration. Takeda plans regulatory submissions in fiscal year 2026 and will continue safety evaluation in an ongoing extension study.
Takeda (NYSE:TAK) reported Phase 3 results showing once-daily oral zasocitinib (TAK-279) produced rapid, durable skin clearance in moderate-to-severe plaque psoriasis. At week 16, sPGA 0/1 rates were 71.4% and 69.2% versus placebo (10.7% and 12.6%) and apremilast (32.1% and 29.7%).
PASI90 rates reached 61.3% and 51.9% at week 16; PASI100 reached 33.4% and 25.2%. Responses increased through week 24, and >90% of responders at week 40 maintained response at week 60. Safety was consistent with Phase 2b; no new safety signals. Takeda plans NDA submissions beginning fiscal 2026.
Takeda (NYSE:TAK) and Protagonist announced the FDA accepted the NDA for rusfertide and granted Priority Review with a PDUFA target action date in the third quarter of this calendar year. Rusfertide is a first-in-class hepcidin mimetic for adults with polycythemia vera.
The NDA was based on Phase 3 VERIFY primary and 52-week results plus four-year Phase 2 REVIVE/THRIVE data showing improved hematocrit control, reduced phlebotomy needs, higher clinical response rates versus standard of care, and generally tolerable safety.
Takeda (NYSE:TAK) reported positive Phase 3 KEPLER results showing ENTYVIO (vedolizumab) induced clinical remission in 47.3% of randomized pediatric UC patients at Week 54. The trial enrolled 120 children ages 2–17; 93 responders were randomized to maintenance dosing.
Secondary results: 34.7% remission at Week 14 and 29% sustained remission at Weeks 14 and 54. Safety was consistent with adult experience; most common adverse events included upper respiratory infection (30%), ulcerative colitis worsening (17.5%), and pyrexia (12.5%). Takeda plans regulatory submissions for pediatric IV ENTYVIO.
Takeda (NYSE:TAK) announced FDA acceptance of its New Drug Application and Priority Review for oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA target action date in the third quarter of 2026. The NDA is supported by global Phase 3 FirstLight and RadiantLight studies showing statistically significant, clinically meaningful improvements across wakefulness, excessive daytime sleepiness, cataplexy, attention, and quality of life. Oveporexton is an oral OX2R-selective orexin agonist intended to restore orexin signaling. The drug was generally well tolerated; common adverse events included insomnia, urinary urgency and urinary frequency. The filing does not materially affect Takeda’s fiscal 2026 consolidated forecast.
Takeda (NYSE:TAK) reported FY2025 Q3 results and updated full‑year outlook on January 29, 2026. Q3 YTD revenue fell to ¥3,411.2B (-3.3% AER, -2.8% CER); reported operating profit rose to ¥422.4B (+1.2%). Takeda raised FY2025 forecasts reflecting OPEX discipline and FX tailwind while revising revenue guidance lower due to VYVANSE generics. NDAs filed for oveporexton and rusfertide, with an NDA for zasocitinib on track; all three may launch within 18 months.
Takeda (NYSE:TAK) announced U.S. availability of GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with ≤2 µg/mL IgA in a 10% solution, approved as replacement therapy for people aged two years and older with primary immunodeficiency.
GAMMAGARD LIQUID ERC is a ready-to-use liquid that does not require reconstitution, can be given intravenously or subcutaneously, and is offered in 5 g/50 mL and 10 g/100 mL vials. Storage is up to 24 months at 25°C or 36 months refrigerated (2–8°C). The product uses an Enhanced Removal Capability (ERC) manufacturing step to achieve low IgA content.
Takeda (NYSE:TAK) and Protagonist announced submission of a New Drug Application (NDA) to the FDA on January 5, 2026 seeking approval of rusfertide for adults with polycythemia vera (PV). The NDA includes 52-week data from the Phase 3 VERIFY study, which met the primary endpoint and all four key secondary endpoints, showing durable hematocrit control, reduced phlebotomy needs and improved patient-reported outcomes.
Rusfertide is a first-in-class subcutaneous hepcidin mimetic and has received Breakthrough Therapy, Orphan Drug and Fast Track designations. Under the January 2024 collaboration, the NDA filing starts a 120-day period then a 90-day opt-out decision window for Protagonist, with up to $400 million in opt-out payments and 14–29% tiered royalties possible.
Takeda (NYSE:TAK) reported positive topline results from two pivotal Phase 3 trials of once-daily oral zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis.
The studies met co-primary endpoints (sPGA 0/1 and PASI 75) at week 16, achieved superiority versus placebo and apremilast, and met all 44 ranked secondary endpoints. More than half of patients reached PASI 90 and about 30% reached PASI 100 by week 16, with responses increasing through week 24. Zasocitinib was generally well-tolerated; most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne. Takeda plans to submit a New Drug Application beginning in fiscal year 2026.