Replimune Skin Cancer Therapy Hopes Revive After Positive FDA Panel Vote - Replimune Group (NASDAQ:REPL)

Replimune Group Inc.

(NASDAQ:REPL) stock more than doubled on Friday after the U.S.

Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted in favor of the company’s IGNYTE study data.

FDA Panel Reviews RP1 Biologics License Application The FDA advisory committee voted 10 to 3 that the results from Replimune’s IGNYTE study on RP1 in combination with Bristol-Myers Squibb Co.’s (NYSE:BMY) Opdivo (nivolumab) for advanced melanoma are clinically meaningful and evaluable.

The panel discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.