The litigation centers on allegations that Capricor Therapeutics made misleading statements regarding its clinical data for Deramiocel, a cell therapy intended for Duchenne muscular dystrophy. According to the complaint, the company modified its pre-specified statistical analysis plan without prior FDA agreement before resubmitting its Biologics License Application. Plaintiffs claim these undisclosed changes created significant regulatory risks that eventually undermined the drug's path to approval, causing financial losses to shareholders when the information reached the market.

Investors wishing to participate in the litigation may contact Phillip Kim at the Rosen Law Firm. While the court has not yet certified a class, individuals can choose their own counsel or remain as absent class members. Serving as a lead plaintiff allows investors to direct the course of the litigation, though it is not a prerequisite for sharing in any eventual settlement recovery.