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Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese multinational corporation, stands as Asia's largest and one of the globe's top 20 pharmaceutical giants by revenue. Headquartered in Tokyo, Takeda operates across approximately 80 countries, merging American and British roots into its vast global presence.
With a revenue of JPY 4.3 trillion in fiscal 2023, Takeda dedicates its efforts predominantly to five therapeutic areas: oncology, gastroenterology, neuroscience, rare diseases, and plasma-derived therapies, which collectively generate more than 80% of its revenue. Takeda’s global footprint is diversified, with 50% of its revenue originating from the US, 20% from Japan, and another 20% from Europe and Canada.
Noteworthy for its robust pipeline and commitment to innovation, Takeda partners with various organizations to push the boundaries of medical research. A recent highlight includes a joint venture with Astellas Pharma Inc. and Sumitomo Mitsui Banking Corporation. This collaboration aims to incubate early drug discovery programs, striving to transition academic breakthroughs into practical medical treatments.
Moreover, Takeda's strategic partnership with Neurocrine Biosciences to develop NBI-1065845, an investigational treatment for major depressive disorder, showcases its dedication to addressing unmet medical needs. The positive Phase 2 results of the SAVITRI™ study underline the potential of NBI-1065845 to provide hope for patients with inadequate responses to existing treatments.
Takeda's philosophy focuses on creating a healthier world through life-transforming treatments in its core areas. Their values-based, R&D-driven approach has sustained their leadership in the pharmaceutical sector for over two centuries.
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.
Takeda Pharmaceutical Company Limited (NYSE:TAK) reported solid financial results for Q1 FY2021, ending June 30, 2021. Revenue increased by 18.4% to 949.6 billion yen ($8.6B), driven by a strong performance from its 14 global brands. Operating profit rose 48.6% to 248.6 billion yen ($2.2B), while net profit surged by 142.8% to 200.4 billion yen ($1.8B). Takeda remains on track to meet its full-year guidance, anticipating five to six regulatory submissions by year-end, fostering optimism for the growth of its innovative pipeline.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a collaboration with Frazier Healthcare Partners to launch HilleVax, Inc. for developing and commercializing its norovirus vaccine candidate, HIL-214. Takeda has licensed exclusive rights for HIL-214's development outside Japan while retaining rights in Japan. The vaccine candidate has shown efficacy in preventing moderate-to-severe norovirus cases and has been studied in nine clinical trials. This partnership allows Takeda to focus on other vaccines, including those for dengue and COVID-19.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced that the FDA granted Breakthrough Therapy Designation to TAK-994, an oral orexin agonist in Phase 2 trials for treating excessive daytime sleepiness (EDS) in narcolepsy type 1 patients. This designation aims to expedite development for serious conditions and indicates promising preliminary clinical data suggesting improved wakefulness metrics. TAK-994 represents a significant step in addressing orexin deficiency in NT1 and is part of Takeda's innovative neuroscience research.
Takeda has announced the results of a phase 3 trial for recombinant von Willebrand factor (rVWF) prophylaxis, presented at the ISTH Virtual Congress 2021. The study involved 23 patients with severe von Willebrand disease (VWD) over 12 months. Results indicated a 91.5% reduction in spontaneous, treated annualized bleeding rates (sABRs) compared to historical data from prior on-demand treatments. No new safety risks were identified, bolstering Takeda's commitment to improving patient outcomes in rare bleeding disorders.
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