Replimune is taking a third swing at U.S. FDA approval for its advanced melanoma therapy RP-1 (vusolimogene oderparepvec) after twice receiving complete response letters. The company said it reached alignment with the agency to resubmit its BLA and that FDA plans to treat the resubmission as “urgent,” citing significant unmet need. Separately, another Replimune update reported its stock reaction to the FDA resubmission alignment, with attention to the recent FDA leadership transition and timing of agency priorities. For biotech teams, the announcement highlights how changes in FDA leadership and evolving regulatory posture can reshape timelines for previously rejected biologics, while keeping resubmission data and endpoint framing central to next review cycles.