Replimune is preparing a third regulatory submission for its melanoma therapy RP1 after the FDA leadership shakeups that surrounded prior review cycles. The company said it will resubmit its biologics license application “in the coming days” and that the FDA indicated it will treat the filing as an “urgent matter” with priority review. RP1 is designed to work in combination with Bristol Myers Squibb’s Opdivo (PD-1) blocker in advanced melanoma with progression after prior PD-1 treatment. Replimune’s earlier BLA rejections were tied to two prior review outcomes—one reported as rejected in July 2025 and another in April—while analysts pointed to shifts in the FDA oncology and CBER leadership landscape. BMO Capital Markets characterized the resubmission as potentially positive but cautioned that it remains unclear what specific review-path changes at the FDA will alter the outcome.