Hagens Berman has filed a securities fraud class action lawsuit against Capricor Therapeutics, Inc. on behalf of investors who purchased shares between December 17, 2025 and July 26, 2026. The suit alleges that Capricor and certain executives made materially false and misleading statements about clinical trial data and the regulatory pathway for its lead product candidate Deramiocel, intended to treat Duchenne muscular dystrophy. Specifically, defendants are accused of failing to disclose that they adopted changes to the pre-specified statistical analysis plan without agreement from the U.S. Food and Drug Administration prior to resubmitting its Biologics License Application. The complaint points to a July 27, 2026 FDA briefing document which revealed that the HOPE-3 study did not meet its pre-specified primary and secondary efficacy endpoints and that multiple versions of the statistical analysis plan had been generated with modifications to endpoint definitions and analytical methods. Following that disclosure, Capricor shares fell about 64% to close at $7. Investors have until September 28, 2026 to seek lead plaintiff status.
Capricor Therapeutics IncSecurities fraud lawsuit and FDA briefing reveal misleading statements about trial data and regulatory pathway.
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