Replimune’s resubmission for oncolytic immunotherapy RP1 in advanced melanoma has cleared an FDA administrative step, with a potential advisory committee timeline in late July and a decision date on or before Aug. 2. The candidate is being pursued for accelerated approval after two prior FDA rejections. RP1’s first rejection in July 2025 cited that the pivotal study did not qualify as an “adequate and well-controlled clinical investigation.” The second rejection in April found the data package “insufficient” to support “substantial evidence of effectiveness.” The resubmission arrives after leadership changes at FDA that contributed to a controversial review backdrop. The FDA will now weigh whether the revised package resolves the agency’s earlier concerns—an outcome that could determine whether accelerated approval is achievable for RP1 or remains blocked.