Capricor Therapeutics Faces Extended FDA Review Amid Securities Lawsuit

The regulatory delay stems from a major amendment to Capricor’s Biologics License Application, which now includes 24-month open-label data and a pivot toward focusing on upper limb function. This move follows a July 2026 Advisory Committee meeting where experts scrutinized the company’s clinical trial results. The litigation centers on allegations that executives misled shareholders regarding the study's statistical analysis plan. Plaintiffs claim the company modified its analysis methods without FDA approval, a discrepancy that allegedly surfaced when the agency published briefing documents in July. Following these revelations, Capricor’s share price dropped 64% in a single day, falling to $7.00. The lawsuit covers investors who purchased securities between December 17, 2025, and July 26, 2026, a period that saw the stock surge 370% on reports of positive trial data before the subsequent collapse. Hagens Berman, the law firm representing the plaintiffs, is currently investigating the full extent of the disclosures and management's characterization of trial endpoints.