The litigation stems from a volatile period between December 2025 and July 2026. Following an announcement of positive Phase 3 results for its investigational therapy, Capricor saw its stock price surge 370%. The company subsequently capitalized on this momentum with a public offering of 6 million shares priced at $25 each. However, the narrative shifted dramatically on July 27, 2026, when FDA briefing documents revealed that management had implemented statistical analysis plan changes without regulatory approval.

These disclosures indicated that the HOPE-3 study failed to meet its primary efficacy endpoints, contradicting earlier company statements. The revelation triggered a 64% collapse in share value, while an FDA Advisory Committee later voted 9–3 against the drug's efficacy. Hagens Berman partner Reed Kathrein is now spearheading the investigation into how the company characterized these trial endpoints. Investors who purchased securities during the class period are eligible to participate in the recovery efforts, with the court-mandated deadline for lead plaintiff applications set for September 28, 2026.