The complaint centers on allegations that Capricor altered its statistical analysis plan for Deramiocel without prior FDA approval before resubmitting its Biologics License Application. According to the filing, the company faced a substantial risk that the drug would be denied approval due to insufficient evidence of effectiveness, yet failed to disclose these vulnerabilities to the public. These alleged omissions are cited as violations of the Securities Exchange Act of 1934.

Shareholders who incurred losses during the specified class period have until September 28, 2026, to seek appointment as lead plaintiff. While legal representation is not required to participate in any potential recovery, the firm is offering consultations with partners Brian Schall and David Schwartz to discuss individual rights. The class action has not yet been certified, leaving investors with the option to act or remain as absent class members.