The FDA rejected Replimune’s oncolytic virus therapy RP1 for melanoma for a second time, underscoring persistent regulatory concerns around the trial data. The agency said the company failed to address issues raised previously about study results, according to coverage of the agency’s rationale. A separate FDA action also highlighted the same therapy class: Replimune received another complete response letter for vusolimogene oderparepvec for advanced melanoma on its April 10 PDUFA date, with shares falling sharply. Together, the repeated rejections signal that the FDA is continuing to scrutinize evidence thresholds for accelerated approvals in immuno-oncology, particularly for complex viral platforms where study design and endpoints remain central to review outcomes.