Astellas Pharma - ALPMY STOCK NEWS

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.

Astellas Pharma Inc. and MBC BioLabs have partnered to launch the Astellas Future Innovator Prize, which offers emerging biotech firms and scientists a year's access to MBC BioLabs' facilities and Astellas' R&D resources. Announced on September 19, 2022, the initiative aims to foster innovation in areas aligned with Astellas' pipeline, including immuno-oncology and genetic regulation. The competition, accepting entries until November 4, 2022, underscores both companies' commitment to advancing healthcare solutions through scientific collaboration.

Astellas, Seagen, and Merck announced significant findings from the phase 1b/2 EV-103 trial, highlighting a 64.5% confirmed objective response rate in unresectable advanced urothelial cancer patients treated with enfortumab vedotin and pembrolizumab. This combination demonstrated promising efficacy as a first-line treatment, with 10.5% achieving complete response. Additionally, median overall survival reached 22.3 months for the combination group. Adverse events mainly included skin reactions and neuropathy. The companies plan to discuss results with regulatory authorities and pursue further studies.

Astellas Pharma announced topline results from the Phase 3 MOONLIGHT 3 clinical trial evaluating the safety of 30 mg fezolinetant for treating vasomotor symptoms (VMS) related to menopause. Conducted on 150 women in China over 52 weeks, the trial showed results consistent with earlier studies, indicating long-term safety. An NDA submission is under review in the U.S. for fezolinetant, which is not currently approved anywhere. The trial results will not affect the fiscal forecasts for the year ending March 31, 2023.

The FDA has accepted Astellas Pharma's New Drug Application (NDA) for fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) related to menopause. This acceptance, announced on August 18, 2022, is based on the BRIGHT SKY™ program, involving three Phase 3 trials with over 2,800 participants. The PDUFA date is set for February 22, 2023. Astellas anticipates a minor impact on its financial results for the fiscal year ending March 31, 2023. Fezolinetant is designed to alleviate VMS, which affect a significant percentage of menopausal women.