Overview
- FDA briefing documents released July 27, 2026 showed Capricor changed its pre‑specified statistical analysis plan and finalized the plan one day before unblinding, and the agency said those later versions are post‑hoc and exploratory.
- An FDA advisory committee voted 9–3 that the available evidence does not support deramiocel’s efficacy, and the briefing documents and vote triggered a steep share collapse that erased most of the company’s market value.
- Capricor filed a post‑AdCom resubmission that the agency classified as a major amendment on Aug. 24, 2026, which added 24‑month open‑label data and narrowed the requested indication and pushed the PDUFA date to Nov. 22, 2026.
- Multiple plaintiff firms have filed or are soliciting investors to join securities class actions alleging the company and executives made false or misleading statements and failed to disclose the unagreed SAP changes, with a Sept. 28, 2026 deadline to seek lead‑plaintiff status.
- The near‑term consequences include the FDA’s reassessment of efficacy and timing of a decision, court selection of a lead plaintiff that will shape litigation strategy, and potential investor recoveries and corporate financing pressure that could affect patient access and Capricor’s future.