Replimune reached alignment with the FDA to resubmit its advanced melanoma therapy RP-1 (vusolimogene oderparepvec) after two previous complete response letters. The company said the FDA will treat the resubmission as an urgent matter upon receipt and prioritize review in recognition of unmet need. The company’s resubmission targets use of RP-1 in combination with nivolumab in advanced melanoma, aiming to address the data gaps cited in prior FDA responses. Replimune’s announcement follows leadership and agency changes at the FDA that occurred during the resubmission window. For biotech developers, the path back to review underscores how changes in regulatory engagement and dataset positioning can materially affect the timing of potential approval decisions.