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.
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.
Takeda (NYSE:TAK) reported FY2025 first half results for the six months ended Sep 30, 2025, showing mixed performance and an updated full‑year outlook.
Key H1 figures: Revenue ¥2,219.5B (AER -6.9%, CER -3.9%), Reported operating profit ¥253.6B (-27.7% AER), Core operating profit ¥639.2B (-8.8% CER), Net profit ¥112.4B (-40.0%), EPS ¥72 (-39.8%). Cash flow improved: Operating cash flow ¥593.7B (+31.6%) and Adjusted free cash flow ¥525.4B (+112.3%).
Management updated FY2025 guidance to reflect impairment charges related to the gamma delta T‑cell platform and transactional FX; core results are now expected to show a low‑single‑digit % decline. Annual dividend maintained at ¥200.
Takeda (NYSE:TAK) announced that the FDA-approved HyHub and HyHub Duo devices are now available in the U.S. for patients 17 years and older prescribed HYQVIA.
The devices transfer HYQVIA from vials without a needle or pooling bag, reducing preparation steps by up to ~50% for four DVUs (HyHub) and by ~33% for two DVUs (HyHub Duo), while reducing ancillary supplies and offering an optional carrier bag to enable limited mobility during infusion. Devices are provided at no additional cost after training and are intended for use only with HYQVIA.
Takeda (TAK) entered a license and collaboration with Innovent to develop, manufacture and commercialize two late-stage oncology medicines—IBI363 and IBI343—worldwide outside of Greater China, plus an exclusive option to license IBI3001. Takeda will co-develop and co-commercialize IBI363 with a 60/40 Takeda/Innovent cost and U.S. profit split, lead U.S. co-commercialization, and hold exclusive rights outside the U.S. and Greater China. Takeda will develop, manufacture and commercialize IBI343 outside Greater China. Innovent will receive US$1.2 billion upfront (including a US$100 million Takeda equity investment); additional milestones, royalties and option fees may apply. A global Phase 3 for IBI363 in second-line sqNSCLC is expected to begin in the coming months.
Innovent Biologics and Takeda (NYSE:TAK) announced a global strategic collaboration on Oct 21, 2025 to co-develop and commercialize Innovent's next‑gen IO and ADC assets.
Key terms: US$1.2 billion upfront (including a US$100 million equity investment at HK$112.56/share), potential milestones up to US$10.2 billion for a total deal value up to US$11.4 billion, and tiered royalties. IBI363 (PD‑1/IL‑2α) will be co‑developed globally with a 40/60 Innovent/Takeda cost share and U.S. profit/loss split, IBI343 (CLDN18.2 ADC) licensed outside Greater China, and Takeda holds an option on IBI3001 (EGFR/B7H3 ADC).