ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma has submitted a New Drug Application for fezolinetant to the U.S. FDA, targeting moderate to severe vasomotor symptoms (VMS) linked to menopause. Fezolinetant, a nonhormonal investigational therapy, aims to provide a first-in-class treatment option for the 60-80% of individuals experiencing VMS. This NDA follows two pivotal Phase 3 trials, SKYLIGHT 1 and SKYLIGHT 2, which involved over 1,000 women. The safety and efficacy of fezolinetant are still under investigation, with financial implications for the fiscal year ending March 31, 2023.

Astellas Pharma and GO Therapeutics announced a strategic research and license agreement to develop novel Immuno-Oncology therapeutics. The collaboration involves Astellas' subsidiary Xyphos, which will pay GO Therapeutics $20.5 million upfront, with potential total payments up to $763 million based on milestones. GO will lead the discovery of high-affinity antibodies targeting specific glycoproteins, while Astellas will handle clinical development and commercialization. This partnership aims to enhance cancer treatment efficacy with less damage to healthy tissues.

Astellas Pharma will present 13 abstracts at the 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress, focusing on advanced and rare cancers, including prostate and pancreatic cancers. Highlights include findings from Phase 3 and 2 trials for therapies like enfortumab vedotin and zolbetuximab. Presentations aim to enhance treatment strategies for metastatic cancers. Astellas emphasizes its commitment to advancing oncology through innovative research and strategic collaborations, particularly with Pfizer on enzalutamide.

Astellas Pharma reported positive 12-week results from the Phase 3 SKYLIGHT 1 trial for fezolinetant, a nonhormonal treatment for vasomotor symptoms (VMS) related to menopause. The study demonstrated significant reductions in both the frequency and severity of VMS in women taking 30 mg and 45 mg doses of fezolinetant compared to placebo. Adverse events were mainly mild, with headaches reported most frequently. This investigational treatment could provide a first-in-class option if approved, addressing the needs of over 50% of women aged 40 to 64 affected by VMS.

On April 25, 2022, the University of Tokyo and Astellas Pharma Inc. commenced the second phase of their Astellas Alliance Acceleration Program (AAAP) aimed at co-creating new medicines. After establishing a collaborative base during the first phase from September 2020 to March 2022, the second phase will expand partnership involvement across all university institutions. An AAAP-dedicated project manager will enhance collaboration, focusing on innovative drug discovery by merging the university's research expertise with Astellas' drug development know-how.

Astellas Pharma and Seagen announced that the European Commission has approved PADCEV (enfortumab vedotin) for adult patients with advanced urothelial cancer. This approval follows the EV-301 trial, where enfortumab vedotin showed a median overall survival benefit of 3.9 months compared to chemotherapy. The approval is significant for the estimated 204,000 urothelial cancer cases diagnosed in Europe in 2020, offering a new treatment option for patients with limited alternatives.

Astellas Pharma announced topline results from the Phase 3 MOONLIGHT 1™ clinical trial of fezolinetant, a nonhormonal treatment for vasomotor symptoms (VMS) in menopausal women across Asia. The trial, involving 302 participants, showed that fezolinetant 30 mg once daily did not meet predefined efficacy endpoints, despite some numerical improvements. The safety profile remained consistent with earlier observations. The study will continue with full data analysis expected after 24 weeks. No impact on the current fiscal year's financial projections was indicated.

Astellas Pharma announced topline results from the Phase 3 SKYLIGHT 4 trial, which evaluated the long-term safety of fezolinetant, an investigational therapy for moderate to severe vasomotor symptoms (VMS) associated with menopause. The study included over 1,800 women and achieved its primary endpoint related to endometrial health. The common adverse events were headache and COVID-19, consistent with placebo. Astellas aims to submit regulatory filings based on these findings, with hopes of offering a first-in-class, nonhormonal treatment for VMS.