The proposed securities class action covers purchases between Dec. 17, 2025 and July 26, 2026 after FDA briefing documents challenged the company’s statistical analysis changes ahead of a July 29 advisory committee meeting.
Kahn Swick & Foti said a securities class action has been filed against Capricor Therapeutics, Inc. on behalf of investors who purchased or acquired the company’s securities between December 17, 2025 and July 26, 2026. The case, pending in the United States District Court for the Southern District of California, alleges Capricor and certain executives failed to disclose material information during the class period in violation of federal securities laws. The complaint centers on July 27, 2026 FDA (U.S. drug regulator) briefing documents released before a July 29 advisory committee meeting reviewing the Biologics License Application, or BLA (marketing approval filing for biologic drugs), for deramiocel, Capricor’s lead product candidate. Those documents said the company changed its pre-specified statistical analysis plan, or SAP (study data analysis blueprint), and that the final version was not submitted to the FDA for review before the BLA filing, was not discussed, and was not agreed upon. The FDA also said the final SAP was completed one day before the data was unblinded and objected to methodological changes including converting raw change to percent change and back again, saying the approach added unnecessary complexity, undermined accuracy, and lacked scientific justification. It said analyses based on the post-study SAP versions were post-hoc and exploratory, and the briefing materials described deramiocel’s benefit-risk profile as unfavorable given the lack of evidence supporting effectiveness. The lawsuit is captioned Nkamga v. Capricor Therapeutics, Inc., et al., No. 3:26-cv-04385. Investors who suffered losses have until September 28, 2026 to ask the court to appoint them as lead plaintiff, although participation in any recovery does not require serving in that role.