Capricor's Deramiocel Fails Primary Efficacy Endpoints; CAPR Stock Falls 67% Before FDA Advisory Vote on July 29

According to FDA briefing documents released on Monday (July 28), FDA reviewers said Capricor Therapeutics' lead therapy Deramiocel failed to meet its pre-specified primary and secondary efficacy endpoints in a Phase 3 trial, finding no statistically significant difference between the treatment and placebo after 12 months. Reviewers also raised concerns over changes made to the statistical analysis plan after the randomized portion of the study was completed, noting that the final plan was not submitted for review before the company's Biologics License Application.

Capricor's stock tanked more than 67% on the day of the announcement, marking its biggest single-day decline on record. An FDA advisory committee will review the application on July 29, with a final decision expected by August 22, 2026 under the Prescription Drug User Fee Act deadline.