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.

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.