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) reported strong Q3 2022 results with a 13.9% increase in revenue and 4.5% core revenue growth at constant exchange rates. Net profit rose 18.4%, and EPS rose 19.6%. The company approved the dengue vaccine QDENGA® in the EU and received priority review from the U.S. FDA. Takeda also announced an agreement to acquire a TYK2 inhibitor from Nimbus Therapeutics for USD 4 billion, enhancing its pipeline in autoimmune diseases. Despite revenue increases in most segments, oncology revenue fell 13% due to generic competition for VELCADE®.
Takeda Pharmaceutical has secured an exclusive licensing agreement with HUTCHMED for the development and commercialization of fruquintinib outside China, Hong Kong, and Macau. Fruquintinib, an inhibitor targeting VEGFR-1, 2, and 3, is aimed at treating refractory metastatic colorectal cancer (CRC). Takeda will pay HUTCHMED $400 million upfront, with potential additional payments of up to $730 million based on regulatory and sales milestones. The drug has shown promise in clinical trials and received Fast Track designation from the FDA. This partnership aims to enhance Takeda's oncology portfolio and expand treatment options for CRC patients.
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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.
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.
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 $4 billion upfront and up to $2 billion in milestone payments. NDI-034858 is being developed for autoimmune diseases, showing promising Phase 2b results in psoriasis. The acquisition is set to close in the first half of 2023, pending antitrust reviews.
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.