The lawsuit centers on allegations that Capricor Therapeutics misled shareholders regarding its clinical data analysis for Deramiocel. According to the complaint, the company modified its pre-specified statistical analysis plan without securing prior FDA agreement before resubmitting its Biologics License Application. These omissions reportedly created a significant risk that the regulatory body would find the clinical results insufficient to prove the drug's effectiveness for treating Duchenne muscular dystrophy.

The litigation claims that because these operational shifts were withheld, the company’s public statements concerning its business prospects lacked a reasonable basis. Shareholders who purchased stock during the relevant class period may contact Howard G. Smith at 215-638-4847 or via the firm's website to review their legal rights. Participation as a lead plaintiff is optional, as investors may also choose to remain absent members of the class action or retain independent counsel.