FDA Advisory Panel Votes Against Capricor Therapy -- WSJ

By Xavier Martinez

A Food and Drug Administration advisory panel voted 9-3 Wednesday against Capricor Therapeutics' experimental therapy for a Duchenne muscular dystrophy-related heart condition. Panelists expressed concern about how the company analyzed the data to show improvement.

Trading in Capricor's stock was halted for the meeting, a standard practice around these panels, where outside experts make recommendations to the FDA about drugs they are considering for approval. The agency's own scientists don't have to follow the panel's recommendation, but they often do. The FDA is due to decide on the therapy, deramiocel, by late August.

Shares fell more than 60% Monday after the FDA released documents disputing Capricor's reading of its late-stage trial. The company pointed to results showing deramiocel slowed the loss of arm and hand function by 54% compared with a placebo. Results published in the Lancet shortly before Wednesday's meeting backed that finding but showed that the drug had failed a key secondary goal of demonstrating improvement on a measure of heart-pumping strength.

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July 29, 2026 18:25 ET (22:25 GMT)