Replimune won an early August decision timeline for its twice-rejected melanoma candidate RP1, after the FDA accepted a resubmission for accelerated approval. The regulator is expected to schedule an advisory committee meeting in late July, with a verdict due on or before Aug. 2. RP1 has already been turned back twice, with the FDA citing deficiencies ranging from a lack of an “adequate and well-controlled” pivotal basis to an insufficient evidence package to support substantial effectiveness. The resubmission follows leadership changes at the FDA’s top tier, after public controversy surrounding prior denials. If RP1 gains a favorable regulatory path, the decision would materially affect the competitive landscape for next-generation oncolytic immunotherapies in post–PD-1 advanced melanoma.