Replimune’s RP1 (vusolimogene oderparepvec) is bouncing back after an FDA advisory committee vote that supported the therapy despite negative briefing materials. The single-arm IGNYTE Phase I/II registrational cohort and the company’s BLA for RP1 plus nivolumab in anti–PD-1–refractory advanced melanoma were central to the discussion. The FDA panel outcome followed a biotech cycle in which the program earned breakthrough-therapy designation and priority review as the registrational data were reviewed. With RP1 positioned alongside PD-1 blockade, investors and clinicians were watching for a signal that immunotherapy combinations could move forward in a difficult-to-treat segment. For Replimune, the panel vote reduces one regulatory hurdle while leaving the broader pathway and final FDA determination still to be resolved. The next steps will depend on how the agency integrates efficacy, safety, and trial-design considerations from the advisory process.