Takeda Pharm Stock Price, News & Analysis

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.

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 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 (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.