Robbins Geller sets Sept. 28 deadline in Capricor class action
Robbins Geller says investors who bought Capricor Therapeutics securities during a defined period have until Sept. 28, 2026, to seek lead plaintiff status in a federal class action.
Robbins Geller Rudman & Dowd LLP says investors who bought Capricor Therapeutics securities between Dec. 17, 2025, and July 26, 2026, have until Sept. 28, 2026, to ask a federal court to appoint them lead plaintiff in a securities class action.
The suit, filed in the U.S. District Court for the Southern District of California and captioned Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385, targets Capricor and certain top executives.
According to the notice, the case alleges violations of the Securities Exchange Act of 1934 tied to Capricor's lead product candidate, Deramiocel, a cell therapy under development for Duchenne muscular dystrophy. The allegations focus on changes to the pre-specified statistical analysis plan used for Deramiocel clinical data and on whether those changes were agreed to by the Food and Drug Administration before Capricor resubmitted its biologics license application.
The notice says FDA briefing documents released before the July 29, 2026, advisory committee meeting stated that the final statistical analysis plan version was not submitted to FDA for review before the BLA submission and was not discussed or agreed upon. It also says the documents viewed Capricor's post-study analyses as post-hoc and exploratory, and concluded that the benefit-risk assessment for Deramiocel appeared unfavorable without evidence of effectiveness.
Capricor, as described in the notice, said it had engaged fully and transparently with FDA throughout the review process. The notice also says Capricor said the post-hoc analyses relied on SAP version 1.1, which it described as an unsigned internal draft that became obsolete with cohort B and omitted content requested by FDA.
The notice adds that Cantor Fitzgerald said the FDA briefing documents “paint an ugly picture” and raised concerns about data-collection integrity. It also says the complaint alleges Capricor stock fell 64% on July 27, 2026, and another 36% after the advisory committee meeting. The notice further says Medscape reported on July 30, 2026, that the panel voted 9-3 that the available evidence does not support efficacy of deramiocel for DMD-associated cardiomyopathy.
Robbins Geller said investors do not need to serve as lead plaintiff to share in any potential future recovery. The firm also included standard instructions for investors who want to seek appointment as lead plaintiff before the Sept. 28 deadline.
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