Capricor Therapeutics Faces Shareholder Lawsuit Over Deramiocel Disclosures

The complaint, filed by Robbins LLP, concerns investors who purchased Capricor stock between December 17, 2025, and July 26, 2026. Plaintiffs allege that the company withheld critical information about its Biologics License Application for Deramiocel, a cell therapy intended to treat cardiac and skeletal muscle complications in Duchenne muscular dystrophy patients.

According to the allegations, Capricor altered its pre-specified statistical analysis plan for the Phase 3 HOPE-3 trial without obtaining FDA agreement before submission. Internal FDA briefing documents released in July 2026 indicated that the agency viewed these post-hoc analysis changes as exploratory rather than evidentiary. Following the disclosure of these documents, Capricor’s share price plummeted 64%, followed by an additional 36% decline after an FDA advisory committee voted 9-3 against the drug's efficacy.

Capricor has disputed the characterization of its regulatory interactions, maintaining that it engaged transparently with federal officials throughout the process. Investors seeking to serve as lead plaintiff in the class action must apply by September 28, 2026. The litigation remains in its preliminary stages, with the firm operating on a contingency fee basis for participating shareholders.