Replimune’s RP1 won support from an FDA advisory committee, with panelists voting 10-3 that the efficacy data are evaluable and clinically meaningful. The recommendation increases the odds the FDA will grant approval on the planned timeline, after two earlier complete response letters and repeated regulatory pushback. The committee decision focused on whether RP1’s single-arm Ignyte trial results could be interpreted reliably and whether the therapy could deliver benefit in patients whose melanoma progressed after anti–PD-1 treatment. Replimune argued its trial design supports meaningful outcomes in the setting of limited alternatives. The FDA is scheduled to decide by Aug. 2, making the advisory outcome a near-term inflection point for the oncolytic virus program and for the broader gene-and-cell therapy regulatory posture under the current review leadership.