The lawsuit, filed on behalf of shareholders who purchased Capricor stock between December 17, 2025, and July 26, 2026, highlights a stark divergence between company statements and regulatory findings. While Capricor publicly touted its HOPE-3 results as statistically significant, the SEC-regulated complaint alleges the firm omitted that its final analysis plan was revised just one day before data unblinding—a move never sanctioned by the FDA.

The market impact was severe. Following the release of FDA briefing documents that characterized the study's efficacy as unfavorable and noted the lack of an agreed-upon statistical framework, Capricor shares plummeted. Between July 24 and July 30, 2026, the stock dropped approximately 78.7%, representing a loss of $15.08 per share. The disclosures culminated in a 9-3 advisory committee vote against the efficacy of the firm’s drug, deramiocel.

Attorney Joseph E. Levi, representing the plaintiffs, noted that the core issue remains the timing of internal knowledge regarding these unagreed-upon statistical changes. Shareholders have until September 28, 2026, to apply for lead plaintiff status in the Southern District of California. Potential class members are advised to gather brokerage records documenting their transaction history during the specified window to evaluate eligibility for the ongoing litigation.