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.
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Takeda announced the U.S. FDA's acceptance of its Biologics License Application (BLA) resubmission for the investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). This resubmission addresses FDA feedback from a 2019 Complete Response Letter (CRL). The resubmission includes additional data on the SC administration of Entyvio, which is currently available in intravenous form. Takeda expects a decision by the end of 2023. The pivotal VISIBLE 1 trial, assessing the SC formulation, involved 216 adult patients and demonstrated a primary endpoint of clinical remission at week 52. The SC formulation aims to offer patients an alternative to IV infusion, enhancing treatment options.
Takeda has received FDA approval for HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase), enabling treatment of primary immunodeficiency (PI) in children aged 2 to 16. This supplement expands its market presence, as HYQVIA was initially authorized in 2014 for adults. The approval is based on a Phase 3 study demonstrating effective infection protection, showing a mean rate of acute serious bacterial infections (aSBIs) at 0.04 per year, significantly lower than the predefined target. The drug offers a less frequent treatment option (once a month) that can be administered at home after training. Takeda's commitment to plasma-derived therapies is reinforced through this expanded indication, catering to the specific needs of pediatric patients and their families.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced the dosing of the first patient in Takeda’s Phase 3 REDWOOD study for fazirsiran (TAK-999/ARO-AAT), targeting alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD). This event unlocks a $40 million milestone payment from Takeda to Arrowhead. Fazirsiran, an investigational RNA interference therapy, aims to reduce the production of the harmful Z-AAT protein. The study, involving 160 patients, evaluates the drug's efficacy and safety. Fazirsiran has previously received Breakthrough and Orphan Drug Designations from the FDA.
Takeda has announced an investment of $19.5 million in FY2022, granting funds to 21 new U.S. non-profit organizations, bringing its total CSR investment to nearly $40 million. The funds aim to improve equity in health, education, and environment in under-resourced communities. Launched in FY2021, the 'Takeda Cares' program seeks sustainable change by addressing social disparities. The newly funded organizations include food banks, health equity programs, and educational initiatives across major U.S. cities such as Greater Boston, San Diego, and Atlanta. Detailed insights are available in the recently published 'Takeda Cares for Communities Report.'