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Astellas Pharma Inc. is a global pharmaceutical company with operations in over 70 countries. The company focuses on creating innovative drugs to treat diseases with high unmet medical needs by emphasizing Biology and Modality. Beyond traditional pharmaceuticals, Astellas is exploring Rx+® healthcare solutions in collaboration with cutting-edge technology partners. Astellas recently opened a state-of-the-art West Coast Innovation Center in South San Francisco, enhancing its commitment to biotech innovation.
The company is actively involved in research and development, with recent advancements in cancer therapies like zolbetuximab, a monoclonal antibody targeting gastric and gastroesophageal cancers. Astellas' collaborations with Pfizer and Merck, as well as YASKAWA Electric Corporation, demonstrate its commitment to pioneering research and creating new treatment paradigms by integrating pharmaceutical and robotics technologies.
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.
Astellas Pharma and Seagen announce that the CHMP of the EMA has reaffirmed its positive opinion for PADCEV (enfortumab vedotin) as a monotherapy for adults with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a PD-1/L1 inhibitor. This endorsement follows a review of updated safety data and could lead to PADCEV being the first antibody-drug conjugate authorized in the EU for this cancer type. The final decision from the European Commission is awaited.
Seagen and Astellas Pharma announced results from the EV-103 trial evaluating enfortumab vedotin for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin therapy. Data presented at the 2022 ASCO Genitourinary Cancers Symposium showed that 36.4% of the 22 patients achieved a pathologic complete response, with 50% experiencing tumor downstaging. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). Ongoing phase 3 trials will further investigate the drug's efficacy in combination with pembrolizumab.
Astellas Pharma and Seagen reported initial results from Cohort H of the EV-103 trial on PADCEV® (enfortumab vedotin-ejfv) for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin chemotherapy. Of 22 patients analyzed, 36.4% achieved a pathologic complete response, with 50% showing tumor size reduction. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). The results will be presented at the ASCO Genitourinary Cancers Symposium on February 18, 2022.
Astellas Pharma announced positive interim safety data from the FORTIS trial for AT845, a gene replacement therapy for Late-Onset Pompe Disease (LOPD). This Phase I/II trial aims to assess the safety and efficacy of AT845 in adults. As of December 3, 2021, four participants were enrolled, with no serious adverse events reported. One participant had elevated transaminases, a known immune response. The therapy could address the unmet needs of LOPD patients where enzyme replacement therapy is currently the only approved treatment.