Astellas Pharma’s Resubmission for IZERVAY Accepted by FDA

Astellas Pharma ( (JP:4503) ) has shared an announcement.

Astellas Pharma has announced that the U.S. FDA accepted the Class 1 resubmission of the supplemental New Drug Application for IZERVAY, a treatment for geographic atrophy associated with age-related macular degeneration. The application aims to incorporate two-year data from the GATHER2 Phase 3 clinical trial into the U.S. Prescribing Information, with a 60-day review period and a target action date set for February 26, 2025. This minor financial impact reflects Astellas’ continued efforts to enhance its product offerings in the ophthalmology sector.

More about Astellas Pharma

Astellas is a global life sciences company dedicated to developing transformative therapies across multiple disease areas, including oncology, ophthalmology, urology, immunology, and women’s health. The company focuses on turning innovative science into valuable treatments for patients through its robust research and development programs.

YTD Price Performance: 0.15%

Average Trading Volume: 3,614

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $17.41B

See more insights into 4503 stock on TipRanks’ Stock Analysis page.