The complaint alleges that Capricor altered its statistical analysis plan for clinical data related to Deramiocel without prior FDA approval. According to the filing, this deviation occurred before the company resubmitted its Biologics License Application. Plaintiffs argue that the company failed to disclose the high risk that the FDA would reject the application due to insufficient evidence of effectiveness, leading to financial losses for shareholders when the market eventually reacted to these undisclosed regulatory hurdles.

Shareholders have until September 28, 2026, to apply for lead plaintiff status in the case, which addresses alleged violations of the Securities Exchange Act of 1934. While the firm encourages affected investors to discuss their legal standing, the class has not yet been formally certified. Those interested in participating or reviewing their options may reach out to partners Brian Schall or David Schwartz at the Los Angeles-based firm.