Capricor Faces Class Action as FDA Extends Deramiocel Review

The legal action centers on the period between December 17, 2025, and July 26, 2026, a window marked by volatile swings in company valuation. Law firm Hagens Berman alleges that executives misled shareholders regarding the statistical analysis plan (SAP) for the HOPE-3 study. While Capricor initially claimed the study showed statistically significant improvements in Duchenne muscular dystrophy patients, leading to a 370% stock price surge in December 2025, subsequent FDA briefing documents revealed that the company had made unauthorized post-hoc modifications to its data analysis methods.

When these discrepancies surfaced in July 2026, the company's share price plummeted 64% in a single session. The FDA confirmed that the study failed to meet its primary and secondary efficacy endpoints at 12 months, a finding echoed by an advisory committee that voted 9–3 against the drug's efficacy. Reed Kathrein, the Hagens Berman partner leading the investigation, stated that the firm is prioritizing the recovery of investor losses while examining the full scope of management's characterization of trial endpoints. Shareholders who suffered losses during the class period have until late September to apply for lead plaintiff status as the litigation continues to unfold.