Capricor Therapeutics Faces Securities Litigation Over HOPE-3 Trial

The class action lawsuit, filed by Levi & Korsinsky, LLP, centers on claims that Capricor misled shareholders regarding the integrity of its clinical trial data. According to the complaint, the company deviated from its statistical analysis plan (SAP), finalizing a new version just one day before data unblinding without FDA oversight. These procedural lapses allegedly rendered the final analyses post-hoc and exploratory, contradicting the company’s public narrative of statistical significance.

The regulatory scrutiny intensified after FDA briefing documents revealed that the trial’s blinding process was compromised. Notably, hypersensitivity reactions were reported in 42% of patients treated with deramiocel compared to 15% in the placebo group, a disparity that allowed for potential treatment identification. Following the release of these findings and a subsequent 9-3 advisory committee vote against efficacy, Capricor’s share price plummeted from $19.70 to $4.19, representing a 78.7% decline.

Shareholders seeking to serve as lead plaintiff in the case must file motions with the United States District Court for the Southern District of California by September 28, 2026. Joseph E. Levi, lead attorney for the plaintiffs, argues that the alleged failure to disclose trial-conduct issues deprived investors of critical information necessary to evaluate the company’s BLA resubmission and overall regulatory prospects.