The securities class action, spearheaded by Hagens Berman Sobol Shapiro LLP, centers on allegations that Capricor misled shareholders regarding the regulatory pathway for deramiocel, its investigational cell therapy for Duchenne muscular dystrophy. While the company touted positive Phase 3 results in late 2025—which pushed share prices up 370% and facilitated a major public stock offering—FDA briefing documents later exposed a different reality. The agency revealed that Capricor had implemented post-hoc modifications to its Statistical Analysis Plan without prior regulatory consent, resulting in trial data that failed to meet pre-specified efficacy endpoints.
In section Releases
Capricor Therapeutics Investors Face September Deadline in Class Action
Investors who suffered significant losses in Capricor Therapeutics between December 17, 2025, and July 26, 2026, have until September 28, 2026, to seek lead plaintiff status. The move follows a dramatic 64% stock collapse triggered by revelations that the company made unapproved changes to its clinical trial analysis protocols.
Regulatory scrutiny has intensified following the FDA's recent decision to classify a major amendment to the company’s Biologics License Application as a significant hurdle. This move pushed the target action date for deramiocel from August 2026 to November 22, 2026. Reed Kathrein, the Hagens Berman partner heading the investigation, stated that the firm is focused on uncovering the extent to which management characterized trial endpoints and undisclosed modifications to investors. Affected parties are not required to act as lead plaintiff to participate in potential recoveries but must meet the September deadline to petition the court for the role.
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