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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.
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.
Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) has filed its Corporate Governance Report with the Tokyo Stock Exchange, as required for TSE listed companies. This report is based on the Corporate Governance Code effective since June 1, 2018, with a revised version due by December 2021. The report can be accessed on Takeda’s website. An English version has also been submitted to the U.S. Securities and Exchange Commission. For more information about Takeda's corporate governance policies and ESG initiatives, refer to their 2021 Annual Integrated Report.
Takeda announced positive results from final analyses of the Phase 3 HELP Study™ Open-label Extension, demonstrating the long-term efficacy and safety of TAKHZYRO® (lanadelumab) for hereditary angioedema (HAE). The study involved 212 patients, revealing an 87.4% average reduction in attack rates, with up to 92.4% reduction during the steady state. The treatment maintained attack-free status for 58.6% of patients after six months. TAKHZYRO was well-tolerated across various demographics, with 54.7% experiencing treatment-related adverse effects. Results presented at the EAACI Congress reflect an important milestone for HAE management.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has filed its Annual Report on Form 20-F for the fiscal year ending March 31, 2021, with the SEC on June 29, 2021. The report is available on Takeda's website. Additionally, Takeda has published its 2021 Annual Integrated Report, accessible online. The company emphasizes its commitment to research and development in various therapeutic areas, including Oncology and Neuroscience, while offering free hard copies of the Annual Report to shareholders upon request.
Takeda has launched the "In Their Shoes" platform in the Middle East, an immersive simulation program aimed at increasing awareness of Inflammatory Bowel Disease (IBD) among healthcare providers. This innovative program allows participants to experience patient challenges through a mobile app and role-playing scenarios. An evaluation by the University of Westminster revealed significant improvements in empathy and understanding towards IBD patients. Since its inception, over 1,900 participants from more than 30 countries have engaged with the program, enhancing support for those affected by IBD.
Takeda Pharmaceutical Company has reported positive results from the Phase 3 TAK-620-303 (SOLSTICE) trial for the investigational drug TAK-620 (maribavir), aimed at treating cytomegalovirus (CMV) infections in solid organ transplant (SOT) recipients. Achieving a 55.6% clearance rate at Study Week 8 for those treated with maribavir, compared to 26.1% for conventional therapies. Notably, lung transplant recipients showed a 47.5% success rate with maribavir. The trial met its primary endpoint with significantly fewer treatment-related toxicities. Maribavir is designed to offer a safer, more effective alternative for CMV infection treatment.
Takeda announced promising results for its dengue vaccine candidate, TAK-003, showing sustained protection against dengue illness and hospitalization over three years. In the ongoing Phase 3 TIDES trial, involving over 20,000 children and adolescents, TAK-003 demonstrated an overall vaccine efficacy (VE) of 62.0% against confirmed dengue and an impressive 83.6% VE against hospitalized cases. No significant safety risks were identified, reinforcing TAK-003's potential impact in dengue-endemic regions.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced the FDA's acceptance of a New Drug Application for maribavir, targeting CMV infection in organ transplant recipients. This marks a significant milestone, being the fourth new molecular entity submitted for regulatory review within six months. The application is rooted in the pivotal Phase 3 TAK-620-303 trial, showcasing maribavir's potential to reshape post-transplant CMV treatment.
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