Replimune moved to a third attempt for RP1 in advanced melanoma after the FDA’s rejection history and recent leadership turnover at the agency. The company said it will resubmit its biologics license application “in the coming days” and asked for the FDA to treat the filing as “urgent,” a status the agency indicated it would prioritize. RP1 is being evaluated with Bristol Myers Squibb’s PD-1 blocker Opdivo in patients with melanoma that progressed after prior PD-1 treatment. Replimune pointed to “collaborative dialogue” with the FDA, but it did not identify the specific scientific or regulatory changes behind the decision to refile. Analysts flagged that the resubmission arrives alongside high-level departures at FDA, including Vinay Prasad leaving CBER and Marty Makary stepping down as commissioner—events that followed earlier RP1 rejections, one reportedly driven by a different oncology leadership team at the agency.