Capricor said the FDA lifted a previously issued Complete Response Letter and resumed review of its Biologics License Application for deramiocel to treat Duchenne muscular dystrophy cardiomyopathy. The FDA classified the filing as a Class 2 resubmission and set a PDUFA target action date of August 22, 2026. Capricor said its BLA is supported by positive pivotal HOPE-3 Phase 3 results, including achievement of the primary endpoint and all Type I error-controlled secondary endpoints. The company also said it expects to be eligible for a Priority Review Voucher upon potential approval.

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: 202603100925PRIMZONEFULLFEED9668962) on March 10, 2026, and is solely responsible for the information contained therein.