Replimune’s oncolytic immunotherapy RP1 cleared an FDA acceptance hurdle for a third regulatory attempt in advanced melanoma, with a decision expected on or before Aug. 2. The FDA has also signaled an advisory committee meeting in late July as part of the resubmission package. RP1 has been rejected twice previously: first in July 2025 over the FDA’s view that the pivotal study did not qualify as an “adequate and well-controlled” investigation, then again in April when the agency said the data were insufficient to support substantial evidence of effectiveness. The resubmission followed leadership changes inside the FDA and a “collaborative dialogue” that aligned the company and regulator on a path forward. Replimune is pursuing accelerated approval for RP1 combined with Bristol Myers Squibb’s Opdivo (nivolumab) in patients with disease progression after prior PD-1 treatment—an approach that directly tests whether the updated evidence package can overcome prior evidentiary concerns.