KSF says Capricor investors face Sept. 28 deadline in securities suit
Kahn Swick & Foti said Capricor Therapeutics investors have until Sept. 28, 2026, to seek lead-plaintiff appointment in a federal securities case tied to deramiocel and FDA briefing documents.
Kahn Swick & Foti said Capricor Therapeutics investors have until Sept. 28, 2026, to ask a federal court to appoint them lead plaintiff in a securities class action tied to the company’s lead drug candidate, deramiocel.
The notice says the case is pending in the U.S. District Court for the Southern District of California and covers purchases or acquisitions of Capricor securities between Dec. 17, 2025, and July 26, 2026, inclusive. It identifies the case as Nkamga v. Capricor Therapeutics, Inc., et al., No. 3:26-cv-04385.
According to the notice, the complaint alleges Capricor and certain executives failed to disclose material information during the class period, in violation of federal securities laws. In securities cases, lead plaintiffs help steer the litigation on behalf of other investors who say they suffered losses.
The dispute centers on FDA briefing documents published on July 27, 2026, ahead of a July 29 advisory committee meeting to review Capricor’s biologics license application, or BLA, for deramiocel. The notice says the FDA said Capricor changed the pre-specified statistical analysis plan, that the final version was not submitted for FDA review before the BLA filing and was not discussed or agreed upon, and that the final plan was finalized one day before the data was unblinded.
The notice also says the FDA disagreed with changes to the statistical plan, including converting raw change to percent change and then back again, and said analyses based on post-study versions of the plan were post-hoc and exploratory. It further says the FDA briefing documents indicated the benefit-risk profile for deramiocel looked unfavorable because of a lack of evidence supporting effectiveness.
The notice says Capricor stock fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026, on unusually heavy trading volume. It does not attribute the share-price move to Capricor in the notice itself, but links the decline to the FDA briefing documents.
Kahn Swick & Foti, along with partner Charles C. Foti, Jr., is asking investors who bought or otherwise acquired Capricor securities during the class period and suffered a loss to contact the firm before the deadline. The notice provides Lewis Kahn’s toll-free number, email address and a case-page link.
The Sept. 28 lead-plaintiff deadline remains the next stated date in the notice. The underlying federal case will continue in the Southern District of California.
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