Capricor says FDA advisers vote 9-3 against Deramiocel effectiveness in DMD cardiomyopathy

Reuters2026/07/30 13:31

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Capricor disclosed FDA advisers voted 9-3 that evidence did not support Deramiocel’s effectiveness for DMD-related cardiomyopathy; the vote was non-binding.
Upper-limb function discussion was more supportive, citing Phase 3 HOPE-3 evidence on skeletal muscle benefit; no separate benefit-risk vote occurred.
Results have already been presented to the advisory committee; a final FDA decision is due by the Aug. 22, 2026 PDUFA action date.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Capricor Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607300930PRIMZONEFULLFEED9800968) on July 30, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Capricor says FDA advisers vote 9-3 against Deramiocel effectiveness in DMD cardiomyopathy

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