Welcome to our dedicated page for Astellas Pharma news (Ticker: ALPMY), a resource for investors and traders seeking the latest updates and insights on Astellas Pharma stock.
News for ASTELLAS PHARMA UNSP/ (ALPMY) centers on the activities of Astellas Pharma Inc., a global life sciences company active in medicinal and botanical manufacturing and pharmaceutical development. Company press releases highlight developments across oncology, ophthalmology, urology, immunology and women’s health, as well as collaborations with partners, startups and academic institutions.
Investors and observers following ALPMY-related news will see frequent oncology updates. Recent items include long-term overall survival data for XTANDI (enzalutamide) in metastatic hormone-sensitive prostate cancer from the ARCHES and ENZAMET trials, and new analyses of PADCEV (enfortumab vedotin) in locally advanced or metastatic urothelial carcinoma. Astellas also announces its broader oncology presence at major meetings such as the ASCO Annual Meeting, where it presents multiple abstracts on approved therapies and pipeline programs, including a selective protein degrader targeting KRAS G12D.
Ophthalmology news features IZERVAY (avacincaptad pegol intravitreal solution), a C5 inhibitor for geographic atrophy secondary to age-related macular degeneration in the United States. Astellas reports new data from the GATHER Phase 3 studies and related analyses at ophthalmology congresses, covering biomarkers, disease mechanisms, patient experience and imaging-based structure–function relationships.
News flow also covers strategic partnerships and ecosystem-building initiatives. Examples include agreements with the Korea Institute of Startup and Entrepreneurship Development and Mitsubishi Research Institute to support drug-discovery startups in Korea and Japan, the Astellas Future Innovator Prize at MBC BioLabs for early-stage biotech companies, and a planned joint venture with YASKAWA Electric Corporation to develop a cell therapy manufacturing platform using the Maholo robot. Additional releases describe patient-centric campaigns such as Patient Advocacy Organization (PAO) Action Week and governance updates on nominees for the Board of Directors. Together, these news items provide a view into Astellas’ research focus, collaborations, patient engagement and corporate oversight relevant to ALPMY.
Astellas Pharma and Seagen announced on Sept. 27, 2021 that Japan's Ministry of Health, Labour and Welfare has approved PADCEV (enfortumab vedotin) for treatment of radically unresectable urothelial carcinoma post-chemotherapy. The approval followed a six-month priority review based on the Phase 3 EV-301 trial, which showed a median overall survival of 12.9 months for PADCEV versus 9.0 months for chemotherapy. This treatment addresses a significant need, as over 24,300 bladder cancer cases are diagnosed annually in Japan, with about 9,500 deaths.
Enfortumab vedotin has received approval in Japan for patients with advanced urothelial carcinoma that cannot be surgically removed. The approval by Japan's MHLW follows a priority review and is mainly based on the global Phase 3 EV-301 clinical trial. In the trial, patients treated with enfortumab vedotin showed a median overall survival of 12.9 months, compared to 9.0 months for those receiving chemotherapy, indicating improved outcomes. This ADC targets Nectin-4, a protein commonly found in bladder cancer cells, addressing a significant unmet medical need in the region.
Astellas Pharma announced the 12-week results from the pivotal Phase 3 SKYLIGHT 2 clinical trial of fezolinetant, aimed at treating moderate to severe vasomotor symptoms (VMS) associated with menopause. The trial demonstrated that both 30 mg and 45 mg doses achieved significant reductions in VMS frequency and severity compared to placebo. Adverse events were reported in 40% of the treatment group, with headache as the most common. The findings underscore the potential of fezolinetant as a non-hormonal treatment option for VMS, with plans for further development and safety studies.
Astellas Venture Management and MBC BioLabs announced the third iteration of the Future Innovator Prize, aimed at supporting entrepreneurial scientists and biotech startups. The competition offers winners a year of access to MBC BioLabs’ facilities and Astellas’ R&D resources. Interested parties can submit their applications until November 1, 2021. The initiative seeks to accelerate novel therapeutic programs, especially in oncology, immunology, and neuroscience. Previous winners have shown potential in addressing unmet medical needs, reflecting a commitment to innovative science for patient benefit.
Astellas Pharma and Pfizer announced that XTANDI (enzalutamide) improved overall survival in the Phase 3 ARCHES trial for men with metastatic hormone-sensitive prostate cancer (mHSPC). The study involved 1,150 patients and showed a 34% reduction in the risk of death (HR=0.66; p<0.0001) compared to placebo. Median OS was not reached in either group. Results are set to be presented at the ESMO Congress. This marks the third stage where enzalutamide has shown survival benefits in advanced prostate cancer, enhancing its clinical profile in earlier disease settings.
Astellas Pharma has reported a serious adverse event in the ASPIRO clinical trial for AT132, aimed at treating X-linked Myotubular Myopathy. A participant, who had developed this adverse event, tragically passed away on September 9, 2021. This incident has prompted Astellas to pause screening and dosing in the trial, which had resumed after a previous FDA clinical hold. The FDA has placed the ASPIRO trial on hold again, pending further review. Astellas remains committed to investigating the findings and continuing the development of AT132.
Astellas Pharma announced a voluntary pause in the ASPIRO clinical trial for AT132, a gene therapy for X-linked Myotubular Myopathy (XLMTM), following a serious adverse event involving abnormal liver function in a participant. This pause affects screening and dosing of new participants, though no Investigational New Drug clinical hold has been issued yet. Since the trial began, 24 participants have received AT132, with past adverse liver events leading to fatalities. Astellas continues to monitor existing participants and will provide updates on the investigation.
Astellas Pharma and FibroGen announced the European Commission's approval of EVRENZO™ (roxadustat) for treating symptomatic anemia linked to chronic kidney disease (CKD) in adults. This makes roxadustat the first oral HIF-PH inhibitor available in the EU, enhancing treatment options for CKD patients. The approval follows a positive opinion from the EMA and triggers a $120 million milestone payment from Astellas to FibroGen. The comprehensive Phase 3 program involved 9,600 patients and demonstrated efficacy in maintaining target hemoglobin levels.
Astellas Venture Management LLC has collaborated with LabCentral to launch the Future Innovator Prize, aimed at supporting early-stage life-sciences startups. This initiative offers one-year access to LabCentral’s lab facilities in Cambridge, Massachusetts, along with Astellas' research capabilities.
Applications for the prize are open from August 18 to September 20, 2021. Astellas plans to award up to two prizes, focusing on innovative research in areas such as oncology and neuroscience, aligning with its R&D strategy to enhance drug development for unmet medical needs.
Astellas Pharma announced FDA approval for its supplemental New Drug Application for PROGRAF (tacrolimus), expanding its use to prevent organ rejection in adult and pediatric lung transplant recipients. This marks a significant growth in PROGRAF's indications, now covering liver, kidney, heart, and lung transplants. The approval is based on real-world evidence from a study of over 15,000 adult and 450 pediatric patients, demonstrating one-year graft survival rates of 90.9% and 91.7% respectively. PROGRAF is currently marketed in around 100 countries and has a consistent safety profile.