Replimune said it will resubmit its biologics license application for RP1 in advanced melanoma in the coming days, marking the therapy’s third attempt after two FDA rejections. The company is pairing RP1 with Bristol Myers Squibb’s Opdivo (nivolumab) for patients with disease progression following prior PD-1 treatment. The resubmission comes as Replimune cites changes in FDA leadership, including the departure of former CBER director Vinay Prasad and Commissioner Marty Makary’s stepping down. Analysts at BMO Capital Markets said the move is potentially positive but uncertain, given they could not verify what specifically changed in review expectations. Replimune added that the FDA has indicated it will treat the resubmission as an “urgent matter” and prioritize its review. The company previously saw RP1 rejected in July 2025 and again in April under the prior leadership context.