Capricor PDUFA date for Deramiocel DMD therapy shifts to Nov. 22, 2026 after FDA review extension

Reuters2026/08/24 13:26

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FDA extended the PDUFA target action date for Capricor’s Deramiocel BLA to Nov. 22, 2026 from Aug. 22, 2026.
Delay follows a major BLA amendment adding 24-month HOPE-3 open-label extension data and additional analyses.
CBER accepted the amendment for review, extending the timeline by three months to evaluate the new submission.

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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-26-100071), on August 24, 2026, and is solely responsible for the information contained therein.

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Capricor PDUFA date for Deramiocel DMD therapy shifts to Nov. 22, 2026 after FDA review extension

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