Replimune said it has reached alignment with the FDA to resubmit its twice-rejected advanced melanoma biologic, RP-1 (vusolimogene oderparepvec), for FDA review. The company is pursuing approval in combination with nivolumab after previously receiving complete response letters. The announcement comes amid a period of FDA leadership churn and heightened scrutiny of controversial review outcomes, with Replimune framing the resubmission as a priority matter for regulators. The company’s stock reaction underscored the market sensitivity to any procedural shift that could change the review timeline. If the resubmitted BLA advances, the therapy would represent a new option for patients with advanced melanoma treated alongside checkpoint blockade, and would further test whether the FDA’s stated data requirements can be satisfied with the package already under review.