Capricor Therapeutics Investors Face September 28 Deadline in Fraud Suit

The legal scrutiny centers on Capricor’s lead product candidate, Deramiocel, intended to treat Duchenne muscular dystrophy. The class action alleges that management misled investors by modifying its statistical analysis plan without U.S. Food and Drug Administration agreement. These discrepancies surfaced on July 27, 2026, when the FDA released briefing documents noting the HOPE-3 study failed to meet its pre-specified efficacy endpoints. Capricor shares plunged 64% that day, closing at $7.00.

Confidence in the company further deteriorated during its Q2 2026 earnings call, where management omitted the standard analyst question-and-answer session, citing ongoing, sensitive regulatory discussions. This silence left shareholders without clarity on trial data integrity or the legal fallout from the FDA's findings. Hagens Berman partner Reed Kathrein, who is leading the investigation, stated that the firm is focused on the scope of how management characterized trial endpoints and the undisclosed modifications that preceded the company's December 2025 public stock offering.