Replimune said it will resubmit its biologics license application for RP1 for advanced melanoma as an urgent matter, aiming to return the therapy to the FDA review queue for a third time. The move follows two prior rejections in 2025 and April, and coincides with high-level FDA leadership changes, including departures tied to prior decision cycles. Replimune will pair RP1 with Bristol Myers Squibb’s Opdivo (nivolumab) in patients with disease progression after prior PD-1 treatment. The company says it has been in “collaborative dialogue” with the FDA to find a “meaningful path forward,” but it did not specify which criteria have changed in a way that could alter the review outcome. Analysts remain cautious that the resubmission’s urgency may reflect altered internal processes rather than new scientific requirements—setting up a high-stakes decision timeline for the melanoma immunotherapy space.