The class action complaint, filed in the U.S. District Court for the Southern District of California under the caption Nkamga v. Capricor Therapeutics, Inc. et al., alleges that the company failed to disclose unauthorized changes to its statistical analysis plan. According to the suit, Capricor modified the methodology for calculating the primary endpoint—PUL 2.0—shortly before the clinical database was unblinded, without securing prior FDA approval.

These concerns reached a breaking point on July 27, 2026, when FDA briefing documents highlighted the post-hoc analytical changes. The disclosure wiped out 64.5% of the company’s market value in a single trading session, as shares fell from $19.70 to $7.00. Subsequent pressure mounted on July 30, 2026, when an advisory committee voted 9-3 that available evidence failed to support the drug's efficacy, driving an additional 36% decline in the stock price. Investors seeking to serve as lead plaintiff in the litigation must file their applications by September 28, 2026.