RP1 (vusolimogene oderparepvec) and OPDIVO (nivolumab) - (IGNYTE-3)

June 26, 2026: Replimune Group, Inc. (NASDAQ: REPL) said the FDA accepted for review its resubmitted Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treatment of advanced melanoma. The agency classified the resubmission as a complete, Class 1 response and set a goal date of August 2, 2026. Replimune was also notified to expect an FDA advisory committee meeting in late July 2026.

The resubmission seeks accelerated approval based on data from the IGNYTE clinical trial evaluating RP1 plus nivolumab in patients with confirmed progression on an anti–PD-1-containing regimen.