The FDA accepted Replimune’s regulatory resubmission for RP1, its oncolytic immunotherapy in advanced melanoma, setting an expected decision on or before Aug. 2. The agency also plans an advisory committee meeting in late July, reflecting the contested nature of the application. RP1 has already been rejected twice: first in July 2025 on grounds that a pivotal study did not qualify as an “adequate and well-controlled clinical investigation,” and again in April due to insufficient evidence to conclude substantial effectiveness. The regulatory controversy previously triggered public debate around FDA leadership and review standards. Replimune is seeking accelerated approval for RP1 in combination with Bristol Myers Squibb’s Opdivo after progression on prior PD-1 therapy. The outcome will be closely read by other developers running refiled biologics submissions under evolving FDA scrutiny.