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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's dengue vaccine candidate TAK-003 has demonstrated significant efficacy, preventing 84% of hospitalizations and 61% of symptomatic dengue cases over 4.5 years. The results from the Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) indicate no important safety risks. TAK-003 is currently under regulatory review for potential licensure in the European Union and select dengue-endemic countries. The study, involving over 20,000 children and adolescents, aims to address the urgent need for effective dengue prevention.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) will present significant oncology data at the ASCO and EHA congresses in June. Key highlights include positive Phase 3 PARADIGM study results involving colorectal cancer in Japanese patients and survival data from the Phase 3 ECHELON-1 trial on Hodgkin lymphoma. Additionally, Takeda will showcase advancements in its pipeline targeting innate immunity for cancer treatment. These presentations reflect Takeda's commitment to improving patient care through innovation and collaboration in oncology.
Moderna has announced that it will assume the role of marketing authorization holder for its COVID-19 vaccine Spikevax™ in Japan starting August 1, 2022. This transition includes taking over all related activities, such as import, regulatory compliance, development, quality assurance, and commercialization. In a collaborative effort, Takeda will continue to provide distribution support during a transitional phase of the national vaccination campaign. Both companies aim to ensure smooth operational implementation during this handover.
Moderna announces it will take over as the marketing authorization holder for its COVID-19 vaccine, SpikevaxTM, in Japan starting August 1, 2022. This transition from Takeda includes responsibilities for import, local regulations, development, quality assurance, and commercialization. Takeda will continue to provide distribution support during a transitional period. This move aims to strengthen Moderna's commercial organization in Japan as it continues to combat the COVID-19 pandemic.
Takeda Pharmaceutical and Seagen announced that their Phase 3 ECHELON-1 trial for ADCETRIS (brentuximab vedotin) achieved key survival metrics in patients with advanced Hodgkin lymphoma. Data showed a 41% reduction in the risk of death compared to standard treatment ABVD, with a 93.9% six-year overall survival rate for the ADCETRIS combination. The results will be presented at the ASCO and EHA Annual Meetings. The safety profile of ADCETRIS remained consistent with prior studies, showing no new safety signals. This trial marks a significant advancement in treatment options for advanced-stage Hodgkin lymphoma patients.
Takeda reported strong FY2021 results, achieving an underlying revenue growth of 7.4% and a reported revenue increase of 11.6%. Key highlights include a robust free cash flow of JPY 943.7 billion ($7.8B) and significant product approvals across regions. FY2022 guidance predicts continued growth with core operating profit expected to reach JPY 1.1 trillion and reported net profit projected to rise by 26.9%. Takeda's innovative pipeline features approximately 40 clinical stage assets.
Takeda announced its presentation of four abstracts at the 2022 Tandem Meetings and ECCMID, focusing on LIVTENCITY (maribavir) for post-transplant cytomegalovirus (CMV) infections. Key findings include a 34.8% reduction in hospitalizations and a 53.8% decrease in hospital stay duration for LIVTENCITY-treated patients compared to conventional therapies. Additionally, subgroup analyses indicate quicker CMV DNA level clearance with LIVTENCITY. These presentations support LIVTENCITY's role as a new treatment option for CMV infections resistant to conventional therapies.
Takeda has received approval from the Japan Ministry of Health for its recombinant protein-based COVID-19 vaccine, Nuvaxovid, for individuals aged 18 and older. The approval covers both primary and booster immunization, based on positive efficacy and safety data from clinical trials conducted in Japan and internationally. Takeda will manufacture the vaccine at its Hikari facility and begin distribution shortly. The financial impact of Nuvaxovid on Takeda's fiscal year ending March 31, 2023, will depend on distribution schedules, with forecasts to be revealed in May 2022.
Takeda has launched the TAKHZYRO® (lanadelumab-flyo) injection in a single-dose prefilled syringe format in the U.S. to prevent hereditary angioedema (HAE) attacks in patients aged 12 and older. Approved by the FDA in February 2022, this user-friendly option aims to enhance patient experience by simplifying the administration process. TAKHZYRO has been available since 2018 and shows proven efficacy in preventing HAE attacks, supported by one of the largest clinical studies in the field. Patients and specialty pharmacies will receive guidance for the transition to this new format.
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