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 office by September 28, 2026, for potential appointment as Lead Plaintiff. The legal action stems from Capricor's failed attempt in July 2025 to secure FDA approval of Deramiocel through a Biologics License Application (BLA). The FDA issued a Complete Response Letter citing insufficient evidence of effectiveness and the need for additional clinical data. In March 2026, Capricor claimed it had resolved these issues; however, briefing documents ahead of an advisory committee meeting revealed that changes to its statistical analysis plan were not reviewed by the FDA before submission. The FDA criticized these post-hoc modifications as scientifically unjustified and concluded there was no substantial evidence supporting Deramiocel's efficacy. Following this news in late July 2026, Capricor’s stock price dropped significantly—first falling 64% on July 27 to $7.00 per share before dropping another 36% the next day after an advisory panel voted against its approval.
Tickers: $CAPR
Topics: BLA submission FDA regulatory issues securities fraud stock class period