Portnoy Law Firm said it is advising Capricor Therapeutics, Inc. investors of a proposed class action on behalf of buyers of the company's securities between December 17, 2025 and July 26, 2026, with a lead plaintiff deadline of September 28, 2026. The complaint centers on Capricor's Deramiocel Biologics License Application for Duchenne muscular dystrophy and alleges the company changed its pre-specified statistical analysis plan for clinical data without FDA agreement before resubmitting the application, creating a significant risk that regulators would view the evidence as insufficient for approval. FDA briefing documents released on July 27, 2026 ahead of a July 29 advisory committee meeting said the final analysis plan was not submitted for prior FDA review or agreed upon, described some analyses as post-hoc and exploratory, and said Deramiocel's benefit-risk profile appeared unfavorable without evidence of effectiveness. Capricor said the same day that it had engaged fully and transparently with the FDA and argued the agency's post-hoc analyses relied on an unsigned, incomplete internal draft, while Cantor Fitzgerald said the briefing documents "paint an ugly picture." Capricor shares fell 64% on July 27, according to the complaint, and fell another 36% after Medscape reported on July 30 that the advisory panel voted 9-3 in a non-binding decision that the available evidence did not support Deramiocel's efficacy for treating DMD-associated cardiomyopathy.