Replimune's RP1 gets favorable FDA advisory committee vote 10-3 for advanced melanoma

Replimune Group, Inc.

FDA advisory committee voted 10 to 3 that efficacy results from IGNYTE study are evaluable and clinically meaningful.
RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma after anti-PD-1 progression.
FDA target action date for BLA resubmission is August 2, 2026.
CEO Sushil Patel expressed gratitude and looks forward to working with FDA.

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