Capricor Therapeutics Investors Face September 28 Deadline in Lawsuit

The litigation centers on claims that Capricor executives modified the pre-specified statistical analysis plan for the HOPE-3 study without securing necessary FDA approval. These internal adjustments remained undisclosed until July 2026, when regulatory briefing documents revealed that the study failed to meet its primary and secondary efficacy endpoints. The revelation triggered a 64% collapse in Capricor’s share price, closing at $7.00 on July 27, 2026.

This dispute follows a period of extreme volatility for the firm. In December 2025, Capricor reported positive results from the HOPE-3 trial, causing the stock to surge 370% and enabling the company to launch a public offering of 6 million shares at $25 each. Subsequent regulatory scrutiny has since intensified; the FDA recently extended the review period for the company's Biologics License Application to November 22, 2026, following a major amendment submission that included 24-month open-label data. Reed Kathrein, the Hagens Berman partner heading the investigation, stated the firm is prioritizing the extent to which management characterized trial endpoints and the impact of the unapproved statistical modifications. Investors wishing to participate as a lead plaintiff must file their requests by September 28, 2026.