Replimune: FDA Accepts RP1 BLA Resubmission; Decision by Aug 2

Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec). The application is for RP1 in combination with nivolumab for the treatment of advanced melanoma. The FDA has set a goal date of August 2, 2026, for its decision and expects an advisory committee meeting in late July. This resubmission seeks accelerated approval based on data from the IGNYTE clinical trial.