Capricor Therapeutics IncFDA briefing documents raised concerns about post-hoc changes to statistical analysis plan, causing stock drop and fraud investigation.

Bleichmar Fonti & Auld LLP has launched an investigation into Capricor Therapeutics for potential securities fraud following a 64.5% stock drop. The investigation concerns whether Capricor misled investors about clinical data for its lead product candidate Deramiocel, including statements on positive topline results and its regulatory path with the FDA. On July 27, 2026, FDA briefing documents raised concerns about post-hoc changes to Capricor’s statistical analysis plan, specifically alterations to the methodology for calculating the primary endpoint shortly before the database was unlocked. This caused Capricor’s stock to fall $12.70 per share, from a closing price of $19.70 on July 24 to $7.00 on July 27. Investors who held Capricor securities are encouraged to contact the firm to discuss their legal options.
Capricor Therapeutics IncFDA briefing documents raised concerns about post-hoc changes to statistical analysis plan, causing stock drop and fraud investigation.