Replimune said it reached alignment with the U.S. FDA to resubmit its BLA for RP-1 (vusolimogene oderparepvec) in advanced melanoma after two prior rejections. The company characterized FDA interactions as a step toward prioritizing the review after leadership changes at the agency. The resubmission focuses on the combination of RP-1 with nivolumab, targeting an area where developers are competing for differentiated outcomes in checkpoint-eligible disease. For the field, the “third attempt” underscores how gene therapy programs are navigating FDA feedback loops and the importance of resubmission planning after complete response letters.