Capricor Therapeutics Inc. faces a proposed securities class action alleging that it did not disclose changes to Deramiocel's statistical analysis plan and the resulting regulatory risk before the FDA reviewed its Biologics License Application. The lawsuit covers purchasers of Capricor securities from December 17, 2025, through July 26, 2026, and sets a September 28, 2026, deadline for investors seeking appointment as lead plaintiff. The complaint follows FDA briefing documents released before a July 29 advisory committee meeting that questioned the company's post-study analyses and described Deramiocel's benefit-risk assessment as unfavorable without evidence of effectiveness. Capricor shares fell 64% on July 27 and another 36% after the advisory panel's non-binding 9-3 vote that the available evidence did not support Deramiocel's efficacy for DMD-associated cardiomyopathy, according to the complaint.