The complaint alleges that Capricor Therapeutics altered its statistical analysis plan for Deramiocel clinical data without securing prior FDA approval. According to the plaintiff, the company failed to disclose that these unauthorized changes created a significant risk that the agency would reject the drug’s effectiveness, ultimately threatening the Biologics License Application process.
Capricor Therapeutics faces class action over Deramiocel clinical data
Investors who purchased Capricor Therapeutics shares before September 2026 face a critical deadline to join a securities class action lawsuit. Filed in late July, the litigation alleges the company misled shareholders regarding the regulatory status of its Duchenne muscular dystrophy treatment, Deramiocel, prior to recent FDA submissions.
Shareholders who incurred losses following these disclosures have until September 28, 2026, to take action. The Shareholders Foundation, a monitoring service tracking securities litigation, is currently coordinating with affected investors. Those seeking to participate in the recovery efforts should contact the foundation at mail@shareholdersfoundation.com or call 858-779-1554.
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