The complaint alleges that on July 27, 2026, before the market opened, the FDA released briefing documents ahead of its AdCom meeting for Capricor’s resubmitted Dermamiocel Biologics License Application (“BLA”). Further, the complaint alleges that according to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan (“SAP”) and the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.” On July 27, 2026, Capricor’s stock price fell $12.70, or 64%, to close at $7 per share.