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.
The TAK news page on Stock Titan aggregates company-specific coverage for Takeda Pharmaceutical Company Limited American Depositary Shares (NYSE: TAK). Takeda’s own disclosures describe it as a values-based, R&D-driven biopharmaceutical company headquartered in Japan, with core therapeutic and business areas in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Because of this broad focus and active pipeline, Takeda generates frequent news across clinical, regulatory, partnership and financial topics.
Recent press releases highlight late-stage clinical data and regulatory plans for several key programs. In neuroscience, Takeda has presented Phase 3 results for oveporexton (TAK-861), an investigational oral orexin receptor 2 agonist for narcolepsy type 1, showing statistically significant improvements in excessive daytime sleepiness, cataplexy and quality-of-life measures versus placebo. In immunology and dermatology, the company has reported pivotal Phase 3 data for zasocitinib (TAK-279), an investigational highly selective oral TYK2 inhibitor in moderate-to-severe plaque psoriasis, with studies meeting all primary and ranked secondary endpoints.
Takeda news also covers hematology and rare disease developments. Together with Protagonist Therapeutics, the company has released Phase 3 VERIFY and long-term THRIVE data for rusfertide, an investigational hepcidin mimetic for polycythemia vera, demonstrating durable hematocrit control, reduced phlebotomy requirements and maintained patient-reported outcome improvements. In nephrology, Takeda has shared Phase 1b data for mezagitamab (TAK-079) in primary IgA nephropathy, showing stable kidney function and sustained reductions in proteinuria and Gd-IgA1 levels up to 18 months after the last dose.
In vaccines, Takeda has announced seven-year Phase 3 TIDES trial data for its dengue vaccine QDENGA (TAK-003), reinforcing sustained protection against virologically confirmed dengue and dengue-related hospitalizations and supporting a two-dose regimen. Corporate and pipeline news includes strategic oncology collaborations, such as the global partnership with Innovent Biologics for late-stage assets IBI363 and IBI343, and financial updates on revenue trends, generic erosion impacts and revised full-year forecasts.
Investors and followers of TAK can use this news feed to track Takeda’s clinical milestones, regulatory filings, strategic alliances, portfolio prioritization decisions and IFRS-based financial disclosures as they are reported in press releases and SEC Form 6-K submissions.
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.
Takeda (NYSE:TAK) and Protagonist presented 52-week VERIFY and four-year THRIVE data showing durable hematocrit control with rusfertide in polycythemia vera (PV).
Key results: 61.9% of patients on rusfertide maintained absence of phlebotomy eligibility through Week 52; 77.9% of placebo-to-rusfertide crossovers achieved response at Weeks 40–52; mean hematocrit stayed 43% through Week 52. Long‑term data showed a >13‑fold reduction in annual phlebotomy rate (from 9.2 to 0.7 phlebotomies/year). Rusfertide was generally well tolerated with mostly grade 1–2 events.
Innovent Biologics and Takeda (TAK) closed a global strategic collaboration effective Dec 4, 2025 to jointly develop and commercialize next‑generation IO and ADC therapies.
Key deal terms: $1.2B upfront including a $100M equity investment at HK$112.56/share, plus up to $10.2B in development and sales milestones (total deal value up to $11.4B), and potential royalties outside Greater China. Takeda obtains exclusive rights to IBI343 outside Greater China, co‑development/co‑commercialization and U.S. co‑commercial rights for IBI363, and an option for IBI3001 (Phase 1).
Takeda (NYSE:TAK) reported interim Phase 1b data showing sustained kidney benefits from investigational mezagitamab (TAK-079) in primary IgA nephropathy through Week 96 (18 months after last dose).
Key results: mean eGFR change +2.5 mL/min/1.73m2 (95% CI: −1.8, +7.6; n=12), mean proteinuria reduction 55.2% (95% CI: 30.2, 72.6; n=13), Gd-IgA1 −50.1%, hematuria resolved in 60% of patients, and no serious adverse events or opportunistic infections reported.
Mezagitamab has entered Phase 3 enrollment for IgA nephropathy and immune thrombocytopenia and received EU orphan and FDA Breakthrough Therapy designations in 2025.
Takeda (NYSE:TAK) reported 7-year Phase 3 TIDES data showing its dengue vaccine QDENGA (TAK-003) delivers sustained protection across four serotypes and a favorable safety profile.
Key figures: two-dose efficacy vs virologically confirmed dengue was 61.2% at 4.5 years (95% CI: 56.0–65.8); a booster at 4.5 years raised efficacy to 74.3% after 2 years (95% CI: 66.7–80.1). Hospitalization VE was 84.1% at 4.5 years and 90.6% after booster. No new safety signals observed. QDENGA is authorized in 41 countries, WHO-prequalified, with 18.6 million doses distributed in 11 endemic countries as of September 2025.