Capricor Therapeutics Investors Face September Deadline in Class Action

The legal action, led by Hagens Berman Sobol Shapiro LLP, centers on the period between December 17, 2025, and July 26, 2026. Plaintiffs allege that Capricor executives misled the market regarding the efficacy of deramiocel, a cell therapy candidate for Duchenne muscular dystrophy. While the company initially reported positive topline results in December 2025, triggering a 370% surge in share price, subsequent FDA disclosures revealed that the company had modified its statistical analysis plan without regulatory approval.

When these discrepancies surfaced in July 2026, Capricor shares dropped approximately 64% in a single session. The FDA later noted that the HOPE-3 study failed to meet its pre-specified primary and secondary efficacy endpoints. This regulatory scrutiny continues, as the FDA recently extended the review period for the company’s Biologics License Application until November 22, 2026, citing the need to evaluate new data from the study. Reed Kathrein, the partner overseeing the investigation, stated that the firm is examining how management characterized trial endpoints and the impact of the undisclosed modifications on investor losses.