Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

Replimune's FDA advisory committee voted 10-3 that efficacy results from the IGNYTE study for RP1 (in combination with nivolumab) are evaluable and clinically meaningful for treating advanced melanoma in anti-PD-1 therapy-resistant patients. The FDA's target action date for the BLA resubmission is August 2, 2026.