REPL

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

An FDA advisory committee voted 10-3 that IGNYTE study efficacy results for Replimune's RP1 in advanced melanoma are evaluable and clinically meaningful. The favorable panel outcome de-risks the path toward a PDUFA decision and reduces the odds of an outright rejection or request for another trial.