Replimune’s RP1 moved closer to a potential FDA decision after a U.S. advisory panel voted that its efficacy dataset is evaluable and clinically meaningful. The vote, taken by the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, sets up the next regulatory step for the oncolytic virus treatment in unresectable metastatic cutaneous melanoma refractory to PD-1 therapy. The company has already received two complete response letters and resubmitted its BLA in May. The agency’s earlier concerns focused on whether single-arm survival analyses could clearly attribute outcomes to RP1 when administered with background checkpoint inhibition. For investors and clinicians, the adcomm ruling tightens the procedural path—reducing the likelihood of another “not interpretable” outcome—while leaving open how the FDA ultimately weighs the trial design and response evidence ahead of its August 2 target date.