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 MBC BioLabs have announced their sixth annual Astellas Future Innovator Prize competition. The prize offers emerging biotech startups and entrepreneurial scientists one year of priority access to MBC BioLabs' advanced Bay Area facilities, along with access to Astellas' R&D capabilities and business expertise.
The initiative aims to accelerate early drug discovery and research efforts, supporting the development of novel therapeutic programs, modalities, and platforms. Last year's winners were Tipping Point Biosciences and Altay Therapeutics, selected for their potential to address unmet medical needs.
Interested participants have until April 1, 2025 to submit their non-confidential company presentations, including a one-page executive summary.
Astellas Pharma announced FDA approval for expanded labeling of IZERVAY™ (avacincaptad pegol intravitreal solution) for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD), now without dosing duration limitations. The approval follows the company's December 2024 supplemental New Drug Application resubmission.
The expansion is supported by positive GATHER2 Phase 3 trial results through year 2, showing IZERVAY reduced GA lesion growth versus sham treatment, with benefits observed as early as 6 months and doubling over 2 years compared to year 1. Since its April 2024 J-code implementation, over 210,000 vials have been distributed in the U.S. through December 2024.
The treatment demonstrated good tolerability over 2 years, with minimal adverse events and consistent post-marketing safety reporting. The financial impact on Astellas' fiscal year ending March 31, 2025, is expected to be minor.
Astellas Pharma has submitted a New Drug Application (NDA) to Japan's Ministry of Health for avacincaptad pegol (ACP), potentially becoming the first treatment for geographic atrophy (GA) in Japan. GA, affecting over 5 million people globally, is a progressive form of age-related macular degeneration that can cause irreversible vision loss.
The submission is supported by GATHER1 and GATHER2 clinical trials, which demonstrated ACP's ability to slow GA lesion growth with a favorable safety profile over two years. Currently, GA has no approved treatments outside the US and Australia, and an estimated 66% of GA patients may become legally blind or severely visually impaired without timely treatment.
Astellas Pharma has announced significant changes to its management structure, effective April 1, 2025, aimed at enhancing drug discovery and delivery efficiency. The company is establishing several new top management positions:
The new Chief Research & Development Officer (CRDO) role will be filled by Tadaaki Taniguchi, integrating research, development, and Primary Focus teams. Claus Zieler will become the new Chief Commercial & Medical Affairs Officer (CCMAO), combining Commercial and Medical Affairs functions. Rao V. Mantri will join as Chief Manufacturing Officer (CMfgO), and Tatjana Dragovic will assume the new position of General Counsel and Chief Ethics & Compliance Officer (GC & CECO).
These changes will result in the elimination of the CMO, CCO, and CScO roles. Several executives, including Yoshitsugu Shitaka, Hideki Shima, and Catherine Levitt, will resign effective March 31, 2025. Naoki Okamura will continue as President and CEO.
Astellas Pharma announced that the FDA has accepted their revised supplemental New Drug Application (sNDA) for IZERVAY™ on January 6, 2025. The application, designated as a Class 1 resubmission with a 60-day review period, follows a Complete Response Letter from November 2024 and a subsequent meeting with the FDA on December 20, 2024.
IZERVAY™, which was initially approved by the FDA on August 4, 2023, is used for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The current sNDA aims to incorporate positive 2-year data from the GATHER2 Phase 3 clinical trial into the U.S. Prescribing Information. The FDA has set a target action date of February 26, 2025.
The company expects minimal impact on its financial results for the fiscal year ending March 31, 2025.
Astellas Pharma announced that China's NMPA has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® for treating adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This marks the first non-platinum treatment approved in China for this condition in nearly 40 years.
The approval is based on the Phase 3 EV-302 trial results, which showed significant improvements in survival outcomes. The treatment combination achieved a median overall survival of 31.5 months compared to 16.1 months with chemotherapy, representing a 53% reduction in death risk. Additionally, the median progression-free survival was 12.5 months versus 6.3 months with chemotherapy, showing a 55% reduction in cancer progression or death risk.
This approval addresses a significant medical need in China, where over 92,000 people were diagnosed with bladder cancer in 2022, resulting in approximately 41,000 deaths.
Astellas Pharma announced that China's NMPA has approved VYLOY™ (zolbetuximab) for first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma. The approval is specifically for HER2-negative patients whose tumors are claudin (CLDN) 18.2 positive, in combination with chemotherapy.
The approval is supported by Phase 3 GLOW and SPOTLIGHT trials, which showed significant improvements in survival rates. In the GLOW trial, median progression-free survival was 8.21 months with zolbetuximab plus CAPOX versus 6.80 months with placebo. Overall survival was 14.39 versus 12.16 months. The SPOTLIGHT trial showed similar improvements.
This approval is particularly significant as China has the highest number of gastric cancer cases globally, with over 260,000 deaths in 2022. The drug targets CLDN18.2, a biomarker expressed in 35% of Chinese patients with advanced gastric cancer.
Astellas Pharma US has launched 'Cooler Moments' in partnership with Dr. Jen Ashton to address menopausal hot flashes and empower women's health advocacy. The initiative focuses on educating women about moderate to severe vasomotor symptoms (VMS) and available treatment options.
The campaign features Dr. Ashton hosting a video series to debunk menopause myths and discuss VEOZAH, a first-of-its-kind, FDA-approved, hormone-free treatment for reducing moderate to severe hot flashes and night sweats due to menopause. The program includes personal testimonials and aims to encourage open dialogue between women and healthcare providers about menopause management.
Astellas Pharma US has partnered with Desert Oasis Healthcare (DOHC) to pilot DIGITIVA™, a non-invasive digital health solution for heart failure management. DIGITIVA combines the CORE 500™ Digital Stethoscope with a smartphone app featuring AI-driven coaching and educational resources. The system provides clinicians with patient reports highlighting cardioacoustic biomarkers and physiological parameters to enable earlier intervention. The partnership will evaluate DIGITIVA's effectiveness through clinical measures, cost metrics, and patient quality of life assessments using the Kansas City Cardiomyopathy Questionnaire. DIGITIVA received FDA listing in September 2024.
Astellas Pharma Inc. announced FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced gastric and gastroesophageal junction (GEJ) cancer in adults with CLDN18.2-positive tumors. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.
The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials, which met primary endpoints of progression-free survival and overall survival. Approximately 38% of patients screened had CLDN18.2-positive tumors. An FDA-approved companion diagnostic test from Roche is used to identify eligible patients.
VYLOY is now approved in five markets worldwide, including Japan, the UK, EU, South Korea, and the U.S. Astellas has reflected the impact of this approval in its financial forecast for the fiscal year ending March 31, 2025.