Capricor Therapeutics Faces Investor Probe After FDA Data Discrepancies

The volatility began on July 27, 2026, when the FDA published a report ahead of an advisory committee meeting for Deramiocel's biologics license application. While Capricor had previously touted positive topline results from its Phase 3 HOPE-3 study in December 2025—a announcement that sent shares surging 370 percent—the FDA reached a starkly different conclusion. Federal regulators stated the study failed to meet its pre-specified primary and secondary efficacy endpoints.

Central to the investigation is the integrity of Capricor's statistical analysis plan. The FDA briefing revealed that the company modified its analysis plan during the trial, altering endpoint definitions and analytical methods. Hagens Berman partner Reed Kathrein indicated the firm is scrutinizing the extent to which these modifications were disclosed to shareholders. The investigation seeks to determine if these changes were used to paint a misleading picture of the drug's performance before the company launched a 6-million-share public offering at $25 per share late last year.