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 Pharmaceutical Company has announced its acquisition of GammaDelta Therapeutics, a biotech focused on γδ T cell immunotherapy. This strategic move expands Takeda's capabilities in the immuno-oncology space, targeting solid tumors and blood cancers. The acquisition follows a successful collaboration established in 2017 and involves pre-negotiated upfront and milestone payments. With a focus on off-the-shelf therapies, Takeda aims to enhance patient access to innovative cancer treatments. The deal is set to finalize in Q1 of Takeda's fiscal year 2022, pending regulatory review.
BioLife Plasma Services has opened its first plasma donation center in Worcester, Massachusetts, aiming to meet the urgent demand for plasma-derived therapies for rare and chronic conditions. This center is part of a growing network that currently includes over 160 centers across the U.S. BioLife plans to open additional centers, contributing $2-3 million annually to local communities and creating around 70 jobs per location. The center will begin operations on October 16, with an emphasis on providing an industry-leading donor experience.
Takeda announced that the FDA's Antimicrobial Drugs Advisory Committee unanimously recommended maribavir (TAK-620) for treating refractory cytomegalovirus (CMV) infections in transplant recipients. If approved, maribavir will be the first treatment indicated for adults with this condition. The recommendation is based on results from the Phase 2 and Phase 3 TAK-620-303 (SOLSTICE) trials. The FDA is currently conducting a Priority Review of the New Drug Application (NDA) for maribavir, which has also received Breakthrough Therapy and Orphan Drug designations.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has announced the suspension of patient dosing in its Phase 2 studies of TAK-994, an investigational oral orexin agonist, due to a safety signal. This premature cessation aims to reassess the treatment’s benefit/risk profile. Takeda remains committed to patient safety and plans to evaluate all available data for future development decisions regarding TAK-994. The company continues its focus on its orexin franchise, including TAK-861, which is in Phase 1 development.
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Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has announced new partnerships with IntraHealth International, Jhpiego, Pathfinder International, and the World Food Programme, expanding its Global CSR Program. This initiative has contributed JPY 16.5 billion to 20 programs in 72 countries since its launch in 2016. Key commitments include JPY 953 million for nursing education in West Africa and JPY 1.3 billion for the World Food Programme’s logistics project in Ghana. These partnerships aim to enhance healthcare access and improve health systems, benefiting millions globally.
Mirum Pharmaceuticals has entered into an exclusive licensing agreement with Takeda Pharmaceutical Company for the development and commercialization of maralixibat in Japan. This investigational drug targets rare liver diseases such as Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia. Takeda will oversee regulatory approval and conduct clinical studies. Mirum has also submitted a new drug application for maralixibat in the U.S., with a priority review by the FDA expected by September 29, 2021.
Takeda Pharmaceutical Company announced the FDA's approval of EXKIVITY (mobocertinib) for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The approval is based on Phase 1/2 trial results showcasing a median duration of response of approximately 1.5 years. Additionally, a companion diagnostic test was approved to identify eligible patients. This marks Takeda's commitment to addressing the needs of underserved cancer patients, with ongoing efforts to expand treatment options.
Takeda Pharmaceutical Company Limited (NYSE:TAK) announced that its Phase 3 PANTHER study evaluating pevonedistat in combination with azacitidine for higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and low-blast acute myeloid leukemia (AML) did not reach statistical significance for the primary endpoint of event-free survival (EFS). Despite the disappointing outcome, Takeda aims to analyze the full data set to inform future research. The safety profile was consistent with previous reports, and full results will be presented at a medical congress.
BioLife Plasma Services, part of Takeda Pharmaceutical Company, has opened an all-electric plasma donation center in Tukwila, WA. This center initiates a sustainability initiative to address the rising demand for plasma while also tackling environmental challenges. The Tukwila center is part of BioLife's expanding network of over 150 facilities, recognized for high safety standards. Takeda aims for zero carbon emissions by 2040, emphasizing renewable technology and waste reduction. The center opens on August 21, inviting donors who will be compensated for their contributions.