Capricor Therapeutics Faces Class Action Over Deramiocel Data Integrity

The lawsuit, Nkamga v. Capricor Therapeutics, Inc., claims that top executives at the biotechnology firm violated the Securities Exchange Act of 1934 by failing to disclose critical changes made to the drug’s statistical analysis plan. According to the complaint, these modifications were implemented without FDA agreement, creating significant regulatory hurdles for the treatment of Duchenne muscular dystrophy.

Regulatory friction intensified on July 27, 2026, when the FDA released briefing documents questioning the scientific justification of Capricor's data conversion methods. The agency characterized the firm's post-study analyses as exploratory, leading to a 64% drop in the company's share price. Following an advisory committee meeting on July 29, where panelists voted 9-3 that available evidence failed to support the drug's efficacy for cardiomyopathy, the stock declined an additional 36%. Robbins Geller Rudman & Dowd LLP is representing the class, inviting investors who suffered substantial losses to contact attorneys Ken Dolitsky or Michael Albert.