The litigation alleges that Capricor Therapeutics made materially misleading statements regarding its cell therapy, Deramiocel. According to the complaint, the company modified its pre-specified statistical analysis plan for clinical data without prior FDA agreement before resubmitting its Biologics License Application. These undisclosed changes allegedly created significant risks that the FDA would find insufficient evidence of the drug's effectiveness for treating Duchenne muscular dystrophy, ultimately damaging shareholders when the information reached the market.
Rosen Law Firm, which is representing the action, notes that no class has been certified yet, meaning investors are not currently represented by counsel unless they retain their own. Those who purchased during the specified window may participate in the case without upfront costs through a contingency fee arrangement. Investors wishing to serve as lead plaintiff must move the court by the September 28 cutoff, though individual investors may also choose to remain absent members of the class.





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