FDA advisory committee votes AGAINST Replimune RP1 (melanoma)

EHIQ's AdCom model reads REPL as reject-leaning (~70%). The pivotal IGNYTE trial is single-arm with a surrogate ORR primary in a heterogeneous population and unresolved contribution-of-components (RP1 vs nivolumab), the exact deficiencies the FDA named in its July 2025 Complete Response Letter, with no new controlled data added. Panels punish single-arm, surrogate-endpoint packages. Dated before the FDA briefing documents post.