The complaint filed by The Law Offices of Frank R. Cruz alleges that Capricor Therapeutics misled shareholders by failing to disclose critical deviations in its statistical analysis plan for Deramiocel. According to the filing, the company modified its clinical data analysis protocols without prior FDA consent before resubmitting its Biologics License Application. This failure to align with regulatory expectations purportedly created significant risks that the treatment for Duchenne muscular dystrophy would be denied approval, undermining the company’s previous public assertions about its operational prospects.

Legal counsel maintains that these undisclosed facts left investors without a reasonable basis to evaluate the stock's performance. Those who purchased shares during the specified period may contact the firm to participate in the litigation, though class members retain the right to select their own legal representation or remain passive participants in the action.