Capricor Therapeutics shares fell approximately 78.7% after FDA (U.S. drug regulator) briefing documents allegedly revealed that the final HOPE-3 statistical analysis plan had not been submitted for review or agreed with the agency before the biologics license application. The complaint alleges that the FDA treated resulting analyses as post-hoc and exploratory, challenging earlier efficacy claims and the prospects for regulatory approval. CAPR fell from a Class Period high of $35.34 on April 21, 2026, to $4.19 on July 30, after two declines totaling $15.08 per share. The case covers purchases from December 17, 2025, through July 26, 2026, and was filed in the United States District Court for the Southern District of California. The lead plaintiff deadline is September 28, 2026. The FDA advisory committee later voted 9-3 that available evidence did not support efficacy for DMD-associated cardiomyopathy, while Capricor had previously reported HOPE-3 primary and key secondary endpoint significance and announced an August 22, 2026, PDUFA target action date.