The lawsuit, filed by Glancy Prongay Wolke & Rotter LLP, alleges that Capricor Therapeutics failed to disclose critical modifications to the statistical analysis plan used for Deramiocel clinical data. According to the complaint, the company neglected to inform investors that the FDA had not authorized these changes prior to the BLA resubmission. Plaintiffs contend this omission created a significant risk that the drug would fail to demonstrate substantial evidence of effectiveness, jeopardizing regulatory approval for the treatment of Duchenne muscular dystrophy.

Shareholders who purchased securities during the specified period may act as lead plaintiffs or remain absent class members while the case proceeds. Glancy Prongay Wolke & Rotter LLP, a firm recognized for its work in investor recovery, is managing the outreach. Interested parties are directed to contact the firm by September 28, 2026, to participate in the ongoing litigation.