NasdaqGS:REPLBiotechs
Replimune Group (REPL) Is Up 77.0% After FDA Prioritizes RP1 Melanoma BLA Resubmission Path - Has The Bull Case Changed?
Replimune Group, Inc. recently announced that, following collaborative discussions, it has aligned with the U.S. FDA on a prioritized resubmission and review path for its RP1 (vusolimogene oderparepvec) Biologics License Application in combination with nivolumab for patients with advanced melanoma who have progressed on prior anti-PD-1 therapy.
This regulatory step is significant because RP1, an engineered herpes simplex virus designed to enhance tumor killing and immune activation, targets...