The legal action, spearheaded by Hagens Berman Sobol Shapiro LLP, centers on allegations that Capricor misled shareholders regarding the regulatory pathway and statistical analysis plan for deramiocel. According to the complaint, the company allegedly modified its pre-specified analysis plan without FDA approval before resubmitting its Biologics License Application.

These concerns intensified following the publication of FDA briefing documents on July 27, 2026. The agency revealed that the pivotal Phase 3 HOPE-3 study failed to meet its primary and secondary efficacy endpoints, contradicting earlier company claims of statistical significance. The resulting stock decline wiped out gains from a December 2025 rally, during which share prices had surged 370% following initial positive reports. The FDA has since extended the target action date for the drug to November 22, 2026, after classifying recent company submissions as a major amendment. Investors who purchased Capricor securities between December 17, 2025, and July 26, 2026, are being urged to review their legal options as the investigation into the firm's disclosures continues.