Replimune is moving into a third attempt at FDA approval for its melanoma drug RP1 after reaching alignment with the agency on resubmission. The company said it will resubmit the biologics license application for RP-1 (vusolimogene oderparepvec) in combination with nivolumab, targeting advanced melanoma. Replimune emphasized that the FDA plans to treat the resubmission as an urgent matter upon receipt and will prioritize review. The news follows two prior complete response letters in which the FDA cited insufficient data, with Replimune describing newly productive discussions. In parallel, multiple reports note a broader FDA leadership shift that could affect review timelines and agency priorities. The outcome will be watched closely by immuno-oncology developers because RP1’s resubmission is framed around addressing prior evidence gaps while competing in a market dominated by checkpoint combinations and evolving advanced-cell and TME-directed approaches.