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.
The FDA’s target action date under the Class 1 resubmission is August 2, 2026.
FDA Previously Raised Concerns Over IGNYTE Trial
On Tuesday, the FDA staff released briefing documents noting that the single-arm mid-stage study submitted by Replimune to support the approval of the drug as "not interpretable."
In April, the FDA rejected the company’s application for RP1 in combination with nivolumab for advanced melanoma, challenging the agency’s assessment of its data package.
In June 2025, the FDA issued a Complete Response Letter for RP1, indicating that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.
ASCO 2026 Data Highlighted Long-Term Survival
In an oral presentation at the ASCO 2026 annual meeting, RP1 plus nivolumab demonstrated durability in anti-PD-1-failed melanoma patients, with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9 months – including an 83.5% 3-year survival rate among responders.
Capricor’s FDA Advisory Committee Vote Went The Other Way
The update comes after the FDA’s Advisory Committee voted against Capricor Therapeutics Inc.’s (NASDAQ:CAPR) Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
The panel voted 9-3 that the company failed to provide sufficient evidence supporting Deramiocel’s effectiveness, echoing FDA staff concerns over post hoc changes to key analyses after the late-stage trial concluded.
REPL Price Action: Replimune Group shares were up 104.44% at $11.06 at the time of publication on Friday, according to Benzinga Pro data.
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