ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

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.

Astellas Pharma Inc. announced significant management structure changes effective October 1, 2022. Dr. Tadaaki Taniguchi, an experienced oncology surgeon, will take over as Chief Medical Officer (CMO), succeeding Bernhardt Zeiher, who will retire. Additionally, Katsuyoshi Sugita will become Chief People Officer (CPO) following the renaming of the Chief Administrative Officer position. This shift emphasizes Astellas' commitment to human capital in corporate management. The company aims to enhance clinical application and organizational health, aligning with its Corporate Strategic Plan 2021.

Seagen and Astellas announce positive topline results from the phase 1b/2 EV-103 trial evaluating PADCEV combined with KEYTRUDA for treatment of unresectable locally advanced or metastatic urothelial cancer. The trial showed a confirmed objective response rate (ORR) of 64.5% among patients who are ineligible for cisplatin-based chemotherapy. The combination therapy's safety profile aligns with previous studies, prompting plans to discuss these findings with regulatory authorities. Further results will be presented at an upcoming conference.

Astellas Pharma and Seagen announced positive topline results from the phase 1b/2 EV-103 trial evaluating PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab) for unresectable locally advanced or metastatic urothelial cancer. The trial reported a 64.5% confirmed objective response rate (ORR) per independent review. While results align with previous findings, the trial's secondary endpoints will also be assessed. Discussions with regulatory authorities are planned to explore this combination as a new first-line treatment for patients unable to receive cisplatin-based chemotherapy.

Astellas Pharma has announced plans to develop a 154,000-square-foot biotechnology campus in South San Francisco as its West Coast research and innovation center. The investment of approximately $70 million will support collaboration across various business units focused on cell and gene therapies. The facility is set to be operational by summer 2023 and will enhance the co-location of teams currently spread across the Bay Area, thereby improving operational efficiency and advancing treatments for conditions with limited options.

Mogrify Limited and Astellas Pharma have entered a collaborative research agreement focusing on in vivo regenerative medicine to treat sensorineural hearing loss. Mogrify will leverage its cellular reprogramming platform to identify transcription factors that can generate cochlear hair cells, while Astellas will provide research funding and expertise in gene therapy. Approximately 1.57 billion people globally suffer from hearing loss, indicating a significant unmet medical need. The collaboration aims to develop a novel therapy that addresses this gap in treatment.

Astellas Pharma and Sutro Biopharma have entered a worldwide collaboration to develop immunostimulatory antibody-drug conjugates (iADCs), targeting cold tumors resistant to current therapies. Sutro will receive an upfront payment of US$90 million and could earn up to US$422.5 million in additional milestones per product. Astellas aims to enhance its oncology pipeline through this partnership, leveraging both companies' strengths in drug development and commercialization.

Astellas Pharma disclosed that the FDA has placed a clinical hold on the FORTIS Phase 1/2 trial for AT845, a gene therapy for Late-Onset Pompe Disease, due to a serious adverse event (SAE) involving peripheral sensory neuropathy in a participant. The SAE is categorized as Grade 1 (mild) but is serious due to its medical significance. Astellas is collaborating with investigators to monitor the affected patient and is preparing additional data for the FDA. The company is assessing potential financial impacts for the fiscal year ending March 31, 2023.