Robbins Geller sets Sept. 28 deadline in Capricor securities class action

Robbins Geller Rudman & Dowd LLP said investors who bought or acquired Capricor Therapeutics securities between Dec. 17, 2025, and July 26, 2026, have until Monday, Sept. 28, 2026, to ask a federal court to appoint them lead plaintiff in a securities class action.

The notice says the suit, Nkamga v. Capricor Therapeutics, Inc., was filed in the U.S. District Court for the Southern District of California and names Capricor and certain top executives. The filing alleges violations of the Securities Exchange Act of 1934.

The complaint centers on Capricor's lead product candidate, Deramiocel, and allegations about disclosures tied to the therapy's clinical analysis and regulatory review. Capricor describes itself as a biotechnology company focused on cell- and exosome-based therapeutics for Duchenne muscular dystrophy. Deramiocel is described in the notice as a cell therapy aimed at cardiac and skeletal muscle complications linked to the disease.

According to the notice, the complaint alleges Capricor made false or misleading statements, or left out key facts, about changes to the pre-specified statistical analysis plan used to analyze Deramiocel data. It also alleges the Food and Drug Administration had not agreed to those changes before Capricor resubmitted the Deramiocel biologics license application.

The notice says the complaint claims those disclosures created a significant risk that FDA would find the clinical results insufficient to show effectiveness and that regulatory approval for Deramiocel was at risk.

The notice says FDA released briefing documents on July 27, 2026, before a July 29 advisory committee meeting. It alleges those documents said the final statistical analysis plan was not submitted for FDA review before the biologics license application was filed and was not discussed or agreed upon. The notice also says FDA viewed some conversion analyses as not scientifically justified and considered analyses based on post-study plan versions to be post-hoc and exploratory.

Capricor responded that same day, according to the notice, saying it had engaged fully and transparently with FDA throughout the review process. The company also said the post-hoc analyses in FDA's briefing materials relied on SAP version 1.1, which it described as an unsigned internal draft that became obsolete after the addition of cohort B.

The notice further says Cantor Fitzgerald issued an investor note saying the FDA's briefing documents