biotechResolvedMiss

FDA advisory committee votes AGAINST Replimune RP1 (melanoma)

Will the FDA Oncologic Drugs Advisory Committee (ODAC) vote UNfavorably (majority against clinical benefit) on RP1 (vusolimogene oderparepvec) + nivolumab for advanced melanoma? (~July 28 2026)

premise not yet verified

EHIQ

70%

Market

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Edge

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Thesis

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.

Resolution

Outcome

Resolved

August 13, 2026

The advisory committee voted 10-3 FAVORABLY that the IGNYTE efficacy results are evaluable and clinically meaningful for RP1 + nivolumab, on 2026-07-30. The call asked whether it would vote UNfavorably, so the outcome is NO and EHIQ's 70% was a MISS. REGISTRATION DEFECT, recorded rather than used as an escape: the call named the Oncologic Drugs Advisory Committee (ODAC) and the review was by the Cellular, Tissue and Gene Therapies Advisory Committee, the same body the Capricor call named correctly; the stated horizon was ~07-28 and the vote was 07-30. Eric ruled 2026-08-13 that it counts as a loss.

Opened

July 18, 2026

Expected resolution

July 28, 2026