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 announced positive results from the Phase 4 EARNEST study of vedolizumab for chronic pouchitis in the New England Journal of Medicine. The study showed that 31% of participants receiving vedolizumab achieved remission at Week 14, compared to 10% on placebo. This superiority continued with 35% remission at Week 34 versus 18% on placebo. The study confirms vedolizumab's efficacy in treating this condition, with no new safety signals reported. The commitment to alleviating chronic inflammatory gastrointestinal conditions is underscored by Takeda's focus on advancing treatment options for affected patients.
Takeda (TSE:4502/NYSE:TAK) announced plans to propose Miki Tsusaka as a new independent external director at the 147th Ordinary Meeting of Shareholders on June 28, 2023. This follows the retirement announcement of Masato Iwasaki, who has served for nearly 40 years, significantly contributing to Takeda's transformation as a global biopharmaceutical leader. Tsusaka brings strong expertise from her role as President of Microsoft Japan and her previous experience at Boston Consulting Group. Takeda emphasizes its commitment to board diversity, aiming to strengthen governance and pursue its vision as a leading digital biopharmaceutical company.
BioLife Plasma Services, part of Takeda, has opened its 200th plasma donation center in the U.S. with new locations in West Springfield, Massachusetts and Pearland, Texas. This expansion is crucial for addressing the increasing demand for life-saving plasma therapies for rare conditions. Each new center generates an estimated $4-5 million in local community contributions and creates around 70 jobs. BioLife emphasizes inclusivity in the donation process and operates over 50 bilingual centers across the U.S., enhancing accessibility for diverse communities.
Takeda's TAK-279, an allosteric TYK2 inhibitor, showed promising results in a Phase 2b clinical trial for moderate-to-severe plaque psoriasis, presented on March 18, 2023, at the AAD Annual Meeting. Involving 259 patients, the trial demonstrated significant efficacy with patients on TAK-279 achieving PASI 75 (44%-67%), PASI 90 (21%-46%), and PASI 100 (10%-33%) compared to placebo (6%, 0%, 0%, respectively; p0.001). Notably, the 2mg dose did not show significant benefits. Nimbus Therapeutics highlighted the unmet need addressed by TAK-279, steering towards further development in immune-mediated diseases.
Takeda has announced promising results from its Phase 2b trial for TAK-279, a selective oral TYK2 inhibitor, showing significant effectiveness in treating moderate-to-severe plaque psoriasis. Patients receiving dosages of 5mg, 15mg, and 30mg achieved Psoriasis Area and Severity Index (PASI) scores of 75, 90, and 100, substantially higher than the placebo. A Phase 3 study is set to commence in FY2023, along with further evaluations in other immune-mediated diseases such as systemic lupus erythematosus and inflammatory bowel disease. The trial involved 259 patients, with mild to moderate adverse events noted.
Hannon Armstrong Sustainable Infrastructure Capital, Inc. (NYSE: HASI) announced the appointment of Kimberly A. Reed and Jeffrey A. Lipson to its Board of Directors effective March 1, 2023. With this change, the Board now comprises 11 members, 9 being independent. Reed, a former chairman and CEO of the U.S. Export-Import Bank, will add valuable regulatory insight and financial expertise. Lipson, who previously served as COO and CFO, assumes the CEO role, marking a leadership transition for HASI, which manages over $9 billion in assets focused on climate solutions.
Takeda announced significant results from the Phase 3 GRAPHITE study, demonstrating that vedolizumab significantly improved intestinal aGvHD-free survival at Day 180 after allo-HSCT, achieving a response rate of 85.5% compared to 70.9% for placebo (p0.001). The study, presented at the 2023 Tandem Meetings, also showed no new safety signals with vedolizumab. This treatment addresses a critical unmet need in managing lower gastrointestinal aGvHD, a serious complication after stem cell transplantation. The study included 333 patients and marks an advancement in understanding vedolizumab's role in gastrointestinal inflammatory conditions.
Takeda has completed the acquisition of Nimbus Lakshmi, Inc., acquiring full shares from Nimbus Therapeutics for about 4 billion USD. This significant transaction, announced on December 13, 2022, and finalized on February 8, 2023, includes acquiring the promising asset TAK-279, a selective oral TYK2 inhibitor. Phase 2b data is scheduled for release in Q4 FY2022, with a Phase 3 study aimed at psoriasis expected to commence in 2023. The acquisition enhances Takeda's late-stage pipeline, with potential applications across various immune-mediated diseases, supporting long-term growth.
Nimbus Therapeutics has completed the acquisition of its subsidiary Nimbus Lakshmi, Inc. by Takeda, with an upfront payment of $4 billion. This acquisition includes Nimbus's TYK2 inhibitor program, featuring the oral drug TAK-279. Nimbus anticipates receiving up to an additional $2 billion in sales-based milestone payments. The drug, designed to treat immune-mediated diseases, has shown promising results in a Phase 2b trial for moderate-to-severe plaque psoriasis, meeting its primary efficacy endpoint. Nimbus retains its pipeline for other therapies targeting cancer and autoimmune diseases.
Takeda has received FDA approval for the expanded use of TAKHZYRO (lanadelumab-flyo) as the first prophylaxis treatment for children aged 2 to 6 years with hereditary angioedema (HAE). This approval is based on efficacy data from the Phase 3 HELP and SPRING studies, showing a reduction in HAE attacks by 94.8% in pediatric patients. Previously, children 2 to <6 years lacked approved prophylactic options. TAKHZYRO is already available in over 60 countries and aims to address the needs of HAE patients through ongoing research and clinical programs.