Capricor Therapeutics Faces Class Action Lawsuit Over Clinical Data

The litigation centers on the period between December 17, 2025, and July 26, 2026. Plaintiffs claim Capricor executives modified the pre-specified statistical analysis plan for the Duchenne muscular dystrophy treatment without FDA approval before submitting their Biologics License Application. These internal changes remained undisclosed while the company touted "strong and definitive evidence" of efficacy, a narrative that propelled shares up 370% in early December 2025 and facilitated a lucrative public offering of 6 million shares.

Confidence evaporated on July 27, 2026, when an FDA briefing document revealed that the HOPE-3 study failed to meet its primary and secondary efficacy endpoints. The agency noted that Capricor had generated multiple versions of its analysis plan, altering endpoint definitions and data imputation methods. Following these revelations, the stock price plummeted 64% in a single session, closing at $7. Reed Kathrein, a partner at Hagens Berman, is spearheading the investigation into how management characterized these trial endpoints. Investors who incurred losses during the class period have until September 28, 2026, to petition for lead plaintiff status.