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# Capricor Therapeutics Passes Mid-Cycle Review
- URL: https://www.fdaweb.com/capricor-therapeutics-passes-mid-cycle-review/
- Published: 2025-05-05T12:00:00.000Z
- Updated: 2026-09-14T15:10:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159120

Capricor Therapeutics says it has completed an FDA mid-cycle review meeting for a BLA seeking approval for deramiocel and its use in treating Duchenne muscular dystrophy (DMD) cardiomyopathy. “During the meeting, FDA stated that no significant deficiencies have been identified by the review committee and that the package is on track for a Prescription Drug User Fee Act (PDUFA) action date of 8/31,” the company says. The agency also confirmed that an upcoming advisory committee meeting will review the submission.

DMD primarily affects males and leads to progressive muscle weakness, loss of mobility, and eventually life-threatening cardiac and respiratory complications. Deramiocel comprises allogeneic cardiosphere-derived cells (CDCs), a type of stromal cell that has shown promising immunomodulatory, antifibrotic, and regenerative effects in preclinical and clinical studies, according to the company. These cells work by secreting extracellular vesicles known as exosomes, which can reprogram macrophages to adopt a healing rather than a pro-inflammatory response.