Capricor Investors Face September Deadline in Securities Class Action

The litigation follows a sharp decline in Capricor’s market value triggered by regulatory scrutiny. According to the complaint, the company allegedly modified its statistical analysis plan for clinical data without prior FDA approval. This omission reportedly created significant uncertainty regarding the drug's efficacy and its path to regulatory clearance.

Market confidence eroded rapidly in late July 2026. On July 27, FDA briefing documents labeled the risk-benefit assessment for Deramiocel as unfavorable, leading to a 64% drop in share price. Two days later, an advisory committee voted 9-3 that available evidence failed to support the drug's efficacy for DMD-associated cardiomyopathy, causing the stock to fall an additional 36%. Faruqi & Faruqi, LLP is now spearheading an investigation into whether these events stemmed from misleading statements made by company executives.