Replimune Group Says FDA Accepts Resubmission Of BLA For RP1 In Combination With Nivolumab For Advanced Melanoma, With August 2 Goal Date And Expects Adcom Meeting In Late July

Replimune Group, Inc. (NASDAQ:REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

The resubmission seeks accelerated approval of RP1 in advanced melanoma based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen.