Investors face September 28 deadline in Capricor Therapeutics lawsuit

The lawsuit, captioned Nkamga v. Capricor Therapeutics, Inc., centers on the development of Deramiocel, a therapy intended to treat Duchenne muscular dystrophy. Plaintiffs allege that the biotechnology company altered its statistical analysis plan for clinical data without FDA approval. According to the complaint, these undisclosed changes created significant regulatory risks that the company failed to communicate to the market.

Market volatility intensified on July 27, 2026, when the FDA released briefing documents ahead of an advisory committee meeting. Regulators noted that the company’s final statistical plan was not reviewed or agreed upon prior to the Biologics License Application submission. Following reports that the FDA considered the company's analyses to be exploratory and post-hoc, Capricor’s stock price dropped 64%. Two days later, an advisory committee voted 9-3 that the available evidence did not support the drug's efficacy, triggering an additional 36% decline in share value.

Robbins Geller Rudman & Dowd LLP is representing the class, inviting those who suffered substantial losses to contact attorneys Ken Dolitsky or Michael Albert. Under the Private Securities Litigation Reform Act of 1995, the lead plaintiff will act on behalf of all class members to direct the litigation process. Participation in potential future recoveries remains available to eligible investors regardless of whether they serve as the lead plaintiff.