Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced Melanoma

Core Viewpoint - The FDA has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment, with a target action date set for April 10, 2026 [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 and headquartered in Woburn, MA [4] - The company's proprietary RPx platform utilizes a potent HSV-1 backbone to enhance immunogenic cell death and systemic anti-tumor immune response [4] Product Information - RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate systemic anti-tumor immune responses [3] Regulatory Progress - The resubmission of the BLA for RP1 is considered a complete response to the FDA's complete response letter received in July 2025, with additional data and analyses included to address agency feedback [2]