Capricor FDA AdCom Deramiocel Rejection

On July 27, 2026, the U.S. United States — Food and Drug Administration released briefing documents ahead of its advisory committee meeting regarding Paragon Therapeutics' Biologics License Application for deramiocel, a cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy. The FDA criticized Capricor's changes to the pre-specified statistical analysis plan, stating that the conversion of raw change to percent change and back was not scientifically justified and that the benefit-risk assessment appeared unfavorable. On this news, Capricor's stock fell sharply, declining as much as 62.39% intraday. On July 29, the advisory committee met and, in a non-binding 9-3 vote, concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy. Following this, Capricor's stock fell another 36% to close at $4.19 per share on July 30. Subsequently, Glancy Prongay & Murray LLP filed a class action lawsuit against Capricor, alleging that the company made materially false and misleading statements and failed to disclose material adverse facts about its business and prospects during the Class Period from December 17, 2025 to July 26, 2026. The lawsuit claims Capricor failed to disclose that it had changed the statistical analysis plan without FDA agreement, creating a significant risk that the FDA would not find substantial evidence of effectiveness. Investors are reminded of the September 28, 2026 deadline to file lead plaintiff motions.