Capricor says FDA sets Nov. 22 PDUFA date for deramiocel in Duchenne muscular dystrophy

Reuters2026/08/24 13:35

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Capricor outlined an FDA review timeline for deramiocel in Duchenne muscular dystrophy, with a PDUFA target date of Nov. 22, 2026.
Phase 3 HOPE-3 met its primary endpoint at 12 months, showing a 4.55% Performance of Upper Limb benefit versus placebo (p=0.029).
Target label focus narrowed to upper-limb impairment in patients older than 9 years, aligning with the HOPE-3 primary endpoint.
Cash balance of USD 238 million, with runway through 2027 excluding potential product revenue or monetization of a priority review voucher.
Priority review voucher eligibility flagged, with an estimated potential sale value of about USD 150-200 million if awarded.

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 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 sets Nov. 22 PDUFA date for deramiocel in Duchenne muscular dystrophy

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