Capricor Therapeutics Faces Securities Class Action Over FDA Disclosures

The complaint centers on allegations that Capricor altered its statistical analysis plan for the drug Deramiocel without prior FDA approval. According to the filing, the company submitted its Biologics License Application despite knowing that the regulatory body had not endorsed these modifications. This failure to secure alignment created a significant risk that the application would lack sufficient evidence of efficacy.

Investors argue that these undisclosed risks rendered the company’s public statements materially misleading throughout the specified class period. When the market eventually accounted for the true status of the Biologics License Application, shareholders incurred substantial financial losses. Those interested in serving as lead plaintiff must file their motions by September 28, 2026. Brian Schall and David Schwartz of the Los Angeles-based firm are overseeing the inquiry into potential recovery for affected parties.