Capricor Therapeutics hit by FDA panel vote and investor lawsuit over DMD therapy

Capricor Therapeutics' lead cell therapy Deramiocel, intended for boys and young men with Duchenne muscular dystrophy, was judged by a U.S. Food and Drug Administration advisory committee to lack sufficient evidence of effectiveness for heart‑related outcomes, with a 9‑3 vote against the therapy. The panel's concerns triggered a sharp sell‑off in the company's shares, which fell about 8% on the latest trading day and are on track for their worst week ever, erasing roughly 80% of the firm’s market capitalization. The FDA is still scheduled to issue a final decision on Deramiocel by August 22.

Separately, law firm Robbins LLP filed a securities class‑action lawsuit on behalf of investors who purchased Capricor stock between December 2025 and July 2026. The complaint alleges the company misled investors about the likelihood of FDA approval and failed to disclose material changes to the statistical analysis plan used in its Phase 3 HOPE‑3 trial. The suit seeks to represent all affected shareholders and urges them to contact the firm for potential lead‑plaintiff status.