Capricor Investors Face September 28 Deadline in Class Action Suit

The litigation, filed in the U.S. District Court for the Southern District of California, alleges that Capricor and its executives violated the Securities Exchange Act by failing to disclose that the company modified its statistical analysis plan for the drug Deramiocel without FDA agreement. These undisclosed changes led to regulatory concerns regarding the clinical effectiveness of the treatment, which is designed for Duchenne muscular dystrophy.

The conflict surfaced on July 27, 2026, when the FDA released briefing documents ahead of an advisory committee meeting. Regulators noted that the final version of the statistical plan was created shortly before data unblinding and had not been reviewed or agreed upon by the agency. Following the disclosure, Capricor’s stock dropped 64%. Two days later, an advisory panel voted 9-3 that the available evidence failed to support the efficacy of Deramiocel, prompting a further 36% decline in the share price.

Robbins Geller Rudman & Dowd LLP is representing the class, inviting investors who sustained significant losses to step forward as lead plaintiffs. Under the Private Securities Litigation Reform Act of 1995, the appointed lead plaintiff will oversee the litigation and select counsel to represent the interests of the entire class.