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# Capricor’s Duchenne Cell Therapy BLA Resubmitted
- URL: https://www.fdaweb.com/capricors-duchenne-cell-therapy-bla-resubmitted/
- Published: 2026-03-10T12:00:00.000Z
- Updated: 2026-09-14T13:35:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160794

FDA has accepted for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat heart complications in patients with Duchenne muscular dystrophy. FDA classified the filing as a Class 2 resubmission and set a new user fee review action target date of 8/22.

The BLA resubmission follows Capricor’s submission of additional clinical data from its HOPE-3 trial after FDA issued a complete response letter on the original BLA 7/2025\. The company says the agency has not identified any new potential review issues since accepting the updated filing.

Capricor CEO **Linda Marbán** said in a statement that results from the HOPE-3 study and other clinical evidence support the therapy’s potential as a first-in-class treatment for Duchenne muscular dystrophy affecting both skeletal and cardiac muscle.

Deramiocel is described as an investigational, first-in-class allogeneic cell therapy designed to preserve cardiac and skeletal muscle function in patients with Duchenne muscular dystrophy, a rare and fatal genetic disease marked by progressive muscle degeneration. The therapy consists of cardiosphere-derived cells that act primarily through exosomes, which are believed to modulate immune responses and reduce fibrosis, the company says.