NasdaqGS:REPLBiotechs
Why Replimune (REPL) Is Up 15.5% After Supportive FDA Panel Vote On IGNYTE Melanoma Data
Replimune Group recently reported that the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 that efficacy results from its single‑arm IGNYTE study of RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma are evaluable and clinically meaningful, ahead of an August 2, 2026 target action date for the resubmitted Biologics License Application.
The decision spotlights Replimune’s proprietary oncolytic herpes simplex virus platform, engineered with a...