The legal action, pending in the United States District Court for the Southern District of California, centers on claims that Capricor executives violated federal securities laws. According to the complaint, the company failed to transparently communicate changes made to its statistical analysis plan for Deramiocel. FDA briefing documents released on July 27, 2026, revealed that these statistical modifications were not submitted for agency review prior to the Biologics License Application, with the final version finalized only one day before data unblinding.
The FDA criticized the adjustments, characterizing the company’s analyses as post-hoc and exploratory rather than scientifically justified. These findings suggested an unfavorable benefit-risk profile for the drug, citing a lack of evidence regarding its effectiveness. Following the release of the FDA documents, Capricor’s stock price plummeted 64%, closing at $7.00 per share on July 27, 2026. Kahn Swick & Foti, LLC is representing investors in the case, Nkamga v. Capricor Therapeutics, Inc., et al., and is currently accepting inquiries from those who incurred losses during the specified period.
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