Replimune said it will resubmit its biologics license application for RP1, its melanoma therapy, shortly after prior FDA rejections in July 2025 and April. The company linked the timing to “collaborative dialogue” with the FDA and to regulator leadership changes that occurred after the earlier decision cycles. Analysts cited by the report note that uncertainty remains about what specifically changed at the agency to alter the review outcome. Replimune indicated the FDA would treat the resubmission as an urgent matter and prioritize review. RP1 is intended for advanced melanoma with progression after prior PD-1 treatment, tested in combination with Bristol Myers Squibb’s Opdivo.