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 approval of EXKIVITY (mobocertinib) in China for treating adults with EGFR Exon20 insertion+ NSCLC who have progressed on platinum-based chemotherapy. This approval follows a Phase 1/2 clinical trial involving 114 patients, revealing a confirmed overall response rate (ORR) of 28% and a median duration of response (DoR) of 15.8 months. EXKIVITY is the first targeted therapy available for this patient group in China, addressing a significant unmet need as lung cancer is prevalent in the region.
Takeda (TSE:4502/NYSE:TAK) and Arrowhead Pharmaceuticals (NASDAQ:ARWR) announced positive results from the Phase 2 SEQUOIA study for fazirsiran in treating liver disease due to alpha-1 antitrypsin deficiency (AATD-LD). Notable findings include a 50% fibrosis regression in patients and a 94% median reduction in liver Z-AAT accumulation. Adverse events were balanced between treatment and placebo groups. A Phase 3 study is set to begin this month, aiming to confirm these promising Phase 2 results.
Takeda has announced encouraging interim results from its pivotal Phase 3 trial for TAK-755, a recombinant ADAMTS13 enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP), a rare blood disorder. The trial demonstrated a 60% reduction in thrombocytopenia events compared to standard care, with significantly fewer adverse events related to TAK-755 (8.9%) versus standard care (47.7%). Takeda plans to seek marketing authorization for TAK-755, aiming to provide a vital treatment option for patients with cTTP, who currently lack approved therapies.
Takeda's AURORA trial results indicate that maribavir achieved a 69.6% CMV clearance rate in hematopoietic stem cell transplant recipients, compared to 77.4% for valganciclovir, but did not meet non-inferiority criteria. However, at Week 16, maribavir showed a maintenance effect of 52.7% compared to 48.5% for valganciclovir. Maribavir demonstrated a favorable safety profile, with lower incidences of treatment-emergent neutropenia (21.2%) compared to valganciclovir (63.5%). Takeda continues to engage with regulatory authorities regarding these outcomes.
Nimbus Therapeutics has entered into a definitive agreement for Takeda to acquire its subsidiary, Nimbus Lakshmi, Inc., along with the TYK2 inhibitor NDI-034858. The deal includes
Takeda has announced its acquisition of NDI-034858 from Nimbus Therapeutics for $4B, aiming to enhance its late-stage pipeline in treating autoimmune diseases. NDI-034858, a selective TYK2 inhibitor, has shown promising Phase 2b results in psoriasis, with expected Phase 3 trials commencing in 2023. This strategic move aligns with Takeda's focus on immune-mediated diseases, potentially leading to significant portfolio expansion and improved patient outcomes. The deal includes milestone payments of $1B upon reaching specified sales targets. Takeda anticipates closing the transaction by FY2022.
Takeda will present 15 company-sponsored and nine collaborative abstracts at the 64th American Society of Hematology Annual Meeting from December 10-13, 2022, in New Orleans. Highlighted presentations include updates from the Phase 3 OPTIC trial of ICLUSIG (ponatinib) and a first-in-human study of Modakafusp Alfa (TAK-573). The research aims to enhance outcomes in patients with hematologic diseases, emphasizing novel treatment mechanisms and the importance of addressing unmet needs in this field.
The European Commission has approved QDENGA (TAK-003), a dengue vaccine for individuals aged four years and older. This makes QDENGA the only dengue vaccine approved in the EU for use, regardless of prior dengue exposure.
Approval is based on extensive clinical studies involving over 28,000 participants, showing 80.2% efficacy in preventing symptomatic dengue and 90.4% in preventing hospitalizations at 18 months. The vaccine is crucial for reducing dengue incidence, which has significantly risen globally. No changes are expected in Takeda's fiscal outlook for FY 2022 due to this approval.
Takeda has announced that the FDA has accepted the Biologics License Application (BLA) for TAK-003, its investigational dengue vaccine. The vaccine is aimed at preventing dengue disease caused by any virus serotype in individuals aged 4 to 60. With increasing dengue incidence and 888 infections reported in the U.S. this year, 96% of which were travel-related, the vaccine could become a crucial preventive option. The BLA is supported by a pivotal Phase 3 trial showing 80.2% efficacy at 12 months. Approval in Indonesia has been achieved, with ongoing regulatory reviews in Europe and other regions.