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Capricor Therapeutics: FDA Advisory Panel Votes 9-3 That Evidence Does Not Support Deramiocel for DMD Cardiomyopathy

Capricor Therapeutics said an FDA advisory committee voted that available evidence did not support Deramiocel's effectiveness for DMD cardiomyopathy (3 for, 9 against, 0 abstain).Key Highlights:Original SEC Filing: CAPRICOR THERAPEUTICS, INC. [ CAPR ] - 8-K - Jul. 30, 2026This is an AI-powered summ…

Capricor Therapeutics said an FDA advisory committee voted that available evidence did not support Deramiocel's effectiveness for DMD cardiomyopathy (3 for, 9 against, 0 abstain).

Key Highlights:

FDA Cellular, Tissue and Gene Therapies Advisory Committee voted 3–9 that evidence did not support Deramiocel for DMD cardiomyopathy.
The committee's recommendation is non‑binding; FDA will consider it with the full administrative record in the BLA review.
PDUFA target action date for the Biologics License Application remains August 22, 2026.
Panel addressed a narrower indication than Capricor proposed; separate discussion was directionally supportive of upper limb (PUL 2.0) data from HOPE‑3.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.