Astellas Pharma - ALPMY STOCK NEWS

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.

iota Biosciences, a subsidiary of Astellas Pharma, has received FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) on a novel implantable bladder device. The device aims to treat underactive bladder (UAB) by delivering electrical stimulation to induce bladder contractions. The FDA granted a staged approval, initially allowing enrollment of three participants, with potential expansion to 10 participants upon successful safety outcomes.

UAB affects up to 28% of men over 50 and 45% of older women with lower urinary tract symptoms. The condition impacts millions worldwide, with current treatment options. This innovative approach could provide an alternative to clean intermittent catheterization, which can be burdensome and risky. The study marks a significant step in Astellas' commitment to expanding treatment options beyond traditional pharmaceuticals through bioelectronic technologies.