Overview
- The lawsuit, filed in the U.S. District Court for the Southern District of California, alleges Capricor misled investors by changing the pre‑specified statistical analysis plan used for Deramiocel and resubmitting its Biologics License Application without FDA agreement.
- The FDA briefing documents, released July 27, 2026, said Capricor did not submit the final statistical analysis plan before the BLA and criticized the firm's conversion method of turning raw change into percent change and then back into raw change as unjustified and less accurate.
- Those FDA findings said the benefit‑risk profile for Deramiocel appears unfavorable without clear evidence of effectiveness, and the disclosures are credited in the complaint with triggering a roughly 64% drop in Capricor's share price.
- Multiple plaintiff firms have filed notices and are soliciting investors to seek lead‑plaintiff status in the case captioned Darren Ngasseu Nkamga v. Capricor Therapeutics, No. 26‑cv‑04385, while the suit remains at the pre‑certification stage and its allegations are unproven.
- The case could affect the BLA review outcome and investor recoveries because court appointment of a lead plaintiff will guide litigation strategy and because a finding that analyses were post‑hoc would weaken evidence of Deramiocel's efficacy, a point investors and regulators will continue to watch.