Class Action Lawsuit Filed Against Capricor Therapeutics Over FDA BLA Issues
Pomerantz Law Firm has filed a class action lawsuit against Capricor Therapeutics (NASDAQ: CAPR), alleging securities fraud or other unlawful business practices. The firm is seeking investors who purchased shares during the Class Period and encourages them to contact its legal team by September 28, 2026. The case centers on issues with Capricor's Biologics License Application for Deramiocel as a treatment for Duchenne muscular dystrophy. In July 2025, the FDA issued a Complete Response Letter citing insufficient evidence of effectiveness and the need for additional clinical data. Despite claims by Capricor that it had addressed these concerns by March 2026, briefing documents released in July 2026 revealed changes to its statistical analysis plan were not reviewed or agreed upon with the FDA before submission. The FDA criticized these post-hoc analyses as scientifically unjustified and concluded there was no evidence of effectiveness for Deramiocel. Following this news, Capricor's stock price dropped significantly on July 27 and again after an advisory committee meeting on July 29, which did not support the drug’s efficacy.
Tickers: $CAPR
Topics: class action lawsuit drug approval process FDA securities fraud