FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy

A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product.

The therapy, called deramiocel, is designed to improve heart and skeletal muscle function in patients with the disease, and the panel was asked to assess its efficacy specifically for DMD‑associated cardiomyopathy.

Patient representatives Buddy Cassidy and Debra Dunn, along with the committee’s acting chair Evan Snyder, voted in favor of the therapy, but their support was outweighed by the majority.

The FDA will make a final decision on the application by August 22, 2026.