The complaint alleges that Capricor Therapeutics failed to disclose critical modifications to the statistical analysis plan for Deramiocel. Specifically, defendants are accused of omitting the fact that the FDA had not vetted these changes prior to the resubmission of the company's Biologics License Application. This oversight created a significant risk that the clinical data would fail to demonstrate the effectiveness required for regulatory approval in treating Duchenne muscular dystrophy.

Shareholders have until September 28, 2026, to apply for the lead plaintiff position. While participation in the lawsuit does not require this formal appointment, those who register with the firm will receive ongoing case updates. The litigation centers on claims that the company’s positive public statements lacked a reasonable basis, ultimately leading to an artificial inflation of share prices at the expense of investors.