Capricor says FDA extends Deramiocel DMD BLA decision date to Nov. 22, 2026 after HOPE-3 data filing

Reuters2026/08/24 13:25

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Capricor disclosed additional Phase 3 HOPE-3 follow-up data supporting deramiocel in Duchenne muscular dystrophy; results were already generated.
The new evidence reinforced a benefit in preserving upper limb function, aligning with the trial’s main outcome without detailing performance metrics.
FDA accepted the submission as a major BLA amendment, extending the PDUFA target action date to Nov. 22, 2026.
The extended review keeps regulatory timing as the key near-term catalyst for deramiocel’s potential US market entry.

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: 202608240925PRIMZONEFULLFEED9814789) on August 24, 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 extends Deramiocel DMD BLA decision date to Nov. 22, 2026 after HOPE-3 data filing

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