biotechResolvedMiss

FDA advisory committee votes favorably on Capricor deramiocel (DMD)

Will the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) vote favorably (majority yes) on deramiocel (CAP-1002) for Duchenne muscular dystrophy? (July 29 2026)

premise not yet verified

EHIQ

60%

Market

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Edge

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Thesis

EHIQ's AdCom model reads CAPR as approve-leaning but fragile (~60%). Confirmatory HOPE-3 is a randomized, double-blind, placebo-controlled RCT that hit a validated functional primary (PUL v2.0), the design panels reward. Swing risk: the cardiomyopathy label rests on LVEF, a surrogate, and the FDA reinstated an advisory committee it had earlier waived. Dated before the FDA briefing documents post.

Resolution

Outcome

Resolved

August 13, 2026

The Cellular, Tissue and Gene Therapies Advisory Committee voted 3 for, 9 against, 0 abstaining on 2026-07-29, the exact horizon date, finding the evidence did not support effectiveness of deramiocel for DMD cardiomyopathy. The call asked whether it would vote favorably, so the outcome is NO and EHIQ's 60% was a MISS. The voting question addressed a narrower indication than Capricor proposed and the vote is non-binding; neither changes the answer to the question as written.

Opened

July 18, 2026

Expected resolution

July 29, 2026

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