The litigation centers on claims that Capricor altered its statistical analysis plan for Deramiocel without prior FDA approval before resubmitting its Biologics License Application. According to the complaint, these undisclosed changes created a significant risk that the drug would fail to demonstrate sufficient efficacy, rendering the company’s public disclosures materially misleading. Shareholders suffered financial losses when the discrepancy between the reported data and the actual regulatory standing of the application became public.

Investors seeking to participate in the litigation must act before the September 28, 2026, deadline. While the class has not yet been formally certified, those who incurred losses during the specified period may contact Brian Schall or David Schwartz at the Los Angeles-based firm to discuss potential lead plaintiff appointments and legal representation.