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# FDA Seeks More Data on Capricor Cell Therapy
- URL: https://www.fdaweb.com/fda-seeks-more-data-on-capricor-cell-therapy/
- Published: 2026-01-20T12:00:00.000Z
- Updated: 2026-09-14T15:31:04.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160512

FDA has asked Capricor Therapeutics for a full clinical study report from the company’s Phase 3 HOPE-3 trial as part of its ongoing BLA review for Deramiocel, a proposed cell therapy for Duchenne muscular dystrophy. The request follows the agency’s review of topline HOPE-3 data that Capricor submitted in late 2025\. According to the company, the agency is seeking the complete clinical study report and supporting data to address issues raised in a Complete Response Letter issued in 7/2025\. The agency did not ask for any new clinical trials or additional patient data, it says.

Capricor expects to submit the requested materials next month to resolve the outstanding items in the Complete Response Letter and allow FDA to continue its BLA review of the application, including setting a new target action date under the Prescription Drug User Fee Act.

Chief Executive Officer **Linda Marban** says the request for the full study report is a routine and appropriate step following FDA’s initial review of topline results. She adds that the HOPE-3 data showed statistically significant and clinically meaningful improvements in skeletal muscle and cardiac function, which are key drivers of disease progression and survival in Duchenne patients.

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.