Capricor faces securities fraud suit after 64% stock drop

Bleichmar Fonti & Auld LLP filed a securities fraud class action against Capricor Therapeutics (NASDAQ: CAPR) and senior executives after the stock plunged 64% on FDA clinical data concerns.

"The FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy," the FDA said in briefing documents released July 27 ahead of its advisory committee meeting.

The complaint alleges Capricor changed the pre-specified statistical analysis plan for Deramiocel clinical data without FDA approval before resubmitting the Biologics License Application. The FDA advisory committee voted 9-3 on July 29 that available evidence does not support Deramiocel's efficacy for Duchenne muscular dystrophy-associated cardiomyopathy, sending shares down another 36%.

Investors who purchased Capricor securities between December 17, 2025 and July 26, 2026 have until September 28, 2026 to seek lead plaintiff status. The lawsuit, captioned Nkamga v. Capricor Therapeutics, No. 26-cv-04385, is pending in the Southern District of California.

The FDA briefing documents stated that the final version of the statistical analysis plan "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon." The final version was created one day before the data was unblinded, and the FDA said it considers the post-study SAP versions "post-hoc and exploratory."

The briefing documents concluded that "the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness." Capricor responded that the post-hoc analyses referenced in the FDA materials "rely on SAP version 1.1, an unsigned incomplete internal draft which became obsolete with the addition of cohort B and did not include content specifically requested by the FDA."

Deramiocel is Capricor's lead cell therapy candidate targeting cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy, a rare genetic disorder characterized by progressive muscle degeneration and premature death. The company focuses on developing cell and exosome-based therapeutics for the condition.

Multiple law firms including Rosen Law Firm, Robbins Geller Rudman & Dowd, Kessler Topaz Meltzer & Check, and Schall Brown & Schwartz have announced the class action, with the lead plaintiff deadline set for September 28, 2026. The Private Securities Litigation Reform Act permits any investor who purchased Capricor securities during the class period to seek appointment as lead plaintiff, typically the movant with the greatest financial interest in the relief sought.

The lawsuit adds legal uncertainty to a company already facing regulatory setbacks for its lead product candidate. Investors will watch for the court's lead plaintiff appointment decision and any further FDA action on the Deramiocel BLA.

This article is for informational purposes only and does not constitute investment advice.