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On July 30, 2026, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 that efficacy…
REPLReplimune Group, Inc.
On July 30, 2026, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 that efficacy results from the IGNYTE study for Replimune’s RP1 (vusolimogene oderparepvec) in combination with nivolumab are evaluable and clinically meaningful. This favorable outcome supports the BLA resubmission for advanced melanoma patients who progressed on prior anti-PD-1 therapy, with a target FDA action date of August 2, 2026. Replimune Group, Inc. is a clinical-stage biotechnology company pioneering novel oncolytic immunotherapies.