Replimune said it will resubmit its biologics license application for RP1 in advanced melanoma after an FDA leadership shakeup that followed two earlier rejections. The company plans to refile in the coming days and described the FDA’s review timeline as an urgent matter. The regulatory history is central to the narrative: Replimune’s second rejection in April came under a different FDA leadership structure, and the company is now pointing to renewed dialogue with the agency. RP1 is being proposed in combination with Bristol Myers Squibb’s Opdivo for melanoma progressing after prior PD-1 treatment. For the sector, the move underscores how changes in regulator personnel and internal review dynamics can affect resubmission strategy for immunotherapy candidates with challenging approval paths.