ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Seagen, Astellas Pharma, and Merck announced the FDA's acceptance of supplemental Biologics License Applications for their combination therapy of PADCEV and KEYTRUDA, targeting locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-based chemotherapy. The FDA granted the applications Priority Review, setting a PDUFA date of April 21, 2023. The combination therapy, previously designated as Breakthrough Therapy, is supported by clinical trial data. Continued research includes a phase 3 study to assess the treatment's efficacy and facilitate potential accelerated approval.

Astellas Pharma, Seagen, and Merck announced that the FDA has accepted their applications for Priority Review of PADCEV® and KEYTRUDA® in combination for treating locally advanced or metastatic urothelial cancer. This therapy aims to provide a new treatment option for patients who cannot receive cisplatin-based chemotherapy. The FDA set a PDUFA date of April 21, 2023, for potential accelerated approval. Supported by data from the EV-103 trial, the combination has shown promise, with additional studies ongoing to further evaluate its effectiveness.

Astellas Pharma's Phase 3 GLOW trial for zolbetuximab has successfully met its primary endpoint for progression-free survival (PFS) and secondary endpoint for overall survival (OS) in patients with CLDN18.2-positive, HER2-negative gastric and gastroesophageal junction (GEJ) cancers. The study, involving 507 patients, compared zolbetuximab plus CAPOX to placebo plus CAPOX. Treatment-emergent adverse events included nausea and vomiting. The results will be presented at a scientific congress and are expected to advance the development of zolbetuximab as a first-line treatment option.

Astellas Venture Management and MBC BioLabs awarded the Future Innovator Prize to Bespoke Biotherapeutics and Cellinfinity Bio, providing them a year of access to state-of-the-art lab facilities in San Francisco. This initiative aims to accelerate early-stage research in immuno-oncology. Astellas received numerous applications, highlighting the innovative potential of these startups. Both companies will benefit from Astellas' expertise and resources, enhancing their ability to develop transformative treatments for solid tumors. The award supports Astellas' commitment to fostering pioneering research in the biotech sector.

Astellas Pharma announced that its Phase 3 SPOTLIGHT trial for zolbetuximab, aimed at treating locally advanced unresectable or metastatic gastric and gastroesophageal junction cancers, has met its primary endpoint of progression-free survival (PFS). The trial involved 566 patients and demonstrated significant improvement in PFS and overall survival compared to the placebo group. The most common adverse events reported were nausea, vomiting, and decreased appetite. Full results are expected to be presented at an upcoming scientific congress.

Astellas Pharma and Taysha Gene Therapies announced a strategic investment of $50 million, acquiring a 15% stake in Taysha while gaining exclusive licensing options for two gene therapy candidates, TSHA-102 and TSHA-120. This collaboration aims to develop therapies for Rett syndrome and Giant Axonal Neuropathy (GAN), addressing significant unmet medical needs. Astellas will also receive a Board observer seat and certain rights regarding potential control changes at Taysha, enhancing their gene therapy capabilities in the central nervous system domain.

Astellas Pharma announced the 52-week results from the Phase 3 SKYLIGHT 4™ study of fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause. The study demonstrated the safety and tolerability of fezolinetant doses of 30 mg and 45 mg once daily. Mild or moderate treatment-emergent adverse events were reported, with headache and COVID-19 being the most common. Regulatory applications for fezolinetant are under review in the U.S. and Europe, aiming to provide a first-in-class option for VMS treatment.

Astellas Pharma and Pantherna Therapeutics have expanded their technology evaluation agreement to focus on mRNA-based regenerative medicine programs. This collaboration aims to leverage Pantherna's proprietary mRNA platform and Astellas' drug discovery capabilities to develop innovative treatments for high unmet medical needs in new target organs. Astellas will provide drug discovery ideas and prepare candidate compounds, while Pantherna offers technical information and support. The partnership reflects a continued commitment to advancing regenerative medicine through direct reprogramming technology.

Astellas Pharma announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) for fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause. The application is backed by results from the BRIGHT SKY program, which included over 2,800 women in Phase 3 clinical trials. Fezolinetant's proposed dosage is 45 mg daily. This acceptance does not affect Astellas' financial forecasts for the fiscal year ending March 31, 2023. The compound's safety and efficacy remain under investigation.