The complaint alleges that Capricor Therapeutics made false and misleading statements about the safety and efficacy of their lead drug candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The complaint claims that while Capricor provided positive updates about deramiocel’s progress toward FDA approval, including a mid-cycle review with no significant deficiencies and a planned advisory committee meeting, they concealed adverse data from the Phase 2 HOPE-2 trial. This led to artificially inflated stock prices, which dropped significantly after key revelations: a May 5, 2025, press release caused a decline from $10.30 to $7.30 per share; a June 20, 2025, report of the FDA canceling an advisory meeting due to skepticism about the drug’s efficacy further reduced the stock price from $11.94 to $8.26; and a July 11, 2025, FDA Complete Response Letter denying the Biologics License Application for insufficient evidence of effectiveness and manufacturing issues caused a final drop from $11.40 to $7.64 per share, resulting in significant investor losses.
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