Takeda Pharm Stock Price, News & Analysis

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.

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.

Takeda Pharmaceutical Company (TSE: 4502/NYSE: TAK) announced the publication of the final results from the Phase 3 HELP Study Open-label Extension (OLE) evaluating TAKHZYRO (lanadelumab) in patients with hereditary angioedema (HAE). The study demonstrated an 87.4% reduction in overall HAE attack rate and a 93.4% decrease in attacks requiring acute treatment. Most patients reported an attack-free period of over 12 months. The safety profile was consistent with previous studies, with 54.7% of patients experiencing treatment-related adverse events, primarily injection site reactions.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a decision from the Irish Tax Appeals Commission on July 30, 2021, upholding a tax assessment related to a break fee from AbbVie Inc. received by Shire plc, which Takeda acquired in January 2019. The assessment amounted to 398 million EUR. Takeda plans to appeal this decision and will record a provision estimated at approximately 63 billion JPY in its financial statements for Q1 FY2021. This provision will not affect Takeda's Core or Underlying financial results for the fiscal year ending March 31, 2022.