Replimune’s RP1 plus nivolumab attempt to move in anti–PD-1–refractory advanced melanoma saw a key shift after an FDA advisory committee vote, with the panel supporting RP1 despite negative briefing materials. Replimune previously secured breakthrough therapy designation and priority review tied to the IGNYTE Phase I/II registrational cohort. The result keeps the review pathway alive for a modality built around intratumoral oncolytic immunotherapy, with investors and clinicians watching whether the FDA aligns with the committee’s recommendation.