The lawsuit, filed by Philadelphia-based firm Berger Montague, targets activity occurring between December 17, 2025, and July 26, 2026. Legal action follows an FDA briefing document release on July 27, 2026, which revealed that Capricor altered its statistical analysis plan without securing prior regulatory agreement. Regulators explicitly rejected these changes, characterizing the firm's data manipulation as scientifically unjustified and exploratory rather than definitive. The FDA briefing concluded that the benefit-risk assessment for Deramiocel appeared unfavorable, effectively stalling the company's primary product candidate.

Following the disclosure, Capricor shares plummeted by $12.70, closing at $7.00 on July 27. Investors who held securities during the class period have until September 28, 2026, to petition the court for appointment as lead plaintiff. Berger Montague is currently coordinating inquiries for affected shareholders through attorneys Andrew Abramowitz and Caitlin Adorni as the litigation proceeds.