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 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.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) received emergency use approval from Japan's Ministry of Health for Moderna's mRNA COVID-19 vaccine, now named COVID-19 Vaccine Moderna Intramuscular Injection. This decision is based on successful Phase 1/2 clinical trial results showing robust immune responses. Following a collaboration with Moderna, Takeda will distribute 50 million vaccine doses in Japan. The positive interim analysis indicated 100% antibody response in vaccinated participants, with no significant safety concerns. Distribution begins immediately.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has announced updated data from the Phase 1/2 trial of mobocertinib (TAK-788) for patients with EGFR Exon20 insertion-positive metastatic non-small cell lung cancer (mNSCLC). Results showed a median overall survival of 24 months with a 28% objective response rate after over a year of follow-up. Mobocertinib is under priority review by the U.S. FDA and could become the first oral therapy targeting EGFR Exon20 mutations, with a manageable safety profile.
Takeda announced that the primary analysis data from the Phase 2 OPTIC trial will be presented at the 57th ASCO and 26th EHA Annual Meetings. The trial evaluated response-based dosing of ICLUSIG (ponatinib) in patients with resistant chronic-phase CML. Key findings indicate the optimal starting dose is 45 mg, with a subsequent reduction to 15 mg upon achieving ≤1% BCR-ABL1IS. The trial demonstrated a good safety profile with manageable rates of arterial occlusive events. This data supports ICLUSIG as a viable option for patients intolerant to prior TKI therapies.
Takeda Pharmaceutical Company Limited (NYSE: TAK) reported financial results for FY2020, ending March 31, 2021, revealing a total revenue of JPY 3,197.8 billion, a decline of 2.8% year-on-year, but an underlying growth of 2.2%. The operating profit surged by 407.2% to JPY 509.3 billion, driven by non-core asset sales. The company aims for mid-single-digit revenue growth, targeting JPY 5 trillion by FY2030, while anticipating FY2021 as a critical year with increased R&D investments and potential for four regulatory approvals. Net profit rose by 749.9% to JPY 376 billion.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has received recognition from the International Society for Pharmaceutical Engineering (ISPE) with two awards for the 2021 Facility of the Year Awards. The new solid pharmaceutical packaging building in Hikari, Japan, won in the ‘Process Intelligence and Innovation’ category, while the Grange Castle facility in Ireland was honored for ‘Facility Integration’. These accolades highlight Takeda's commitment to advanced manufacturing and digital technologies, ensuring high-quality production and efficient supply chains for its oncology treatments.
Takeda Pharmaceutical Company announced that the FDA has granted priority review for its New Drug Application (NDA) for mobocertinib (TAK-788). This oral therapy targets EGFR Exon20 insertion mutations in metastatic non-small cell lung cancer (mNSCLC) patients who have previously undergone platinum-based chemotherapy. Mobocertinib has already received Orphan Drug Designation and Breakthrough Therapy Designation from the FDA. The NDA is based on a Phase 1/2 trial involving 114 patients and is part of the FDA's accelerated approval program, facilitated by Project Orbis.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a conference call on April 6, 2021, to discuss updates on its Wave 1 pipeline portfolio, which includes several New Molecular Entities (NMEs) with regulatory filings expected by year-end FY2021. The agenda features key presentations on innovative treatments, including Maribavir (TAK-620) for post-transplant CMV infection and Soticlestat (TAK-935) for Dravet Syndrome. Takeda emphasizes its focus on organic and sustainable revenue growth over the coming years.