The legal action centers on disclosures made ahead of a July 2026 FDA advisory committee meeting. Briefing documents revealed that Capricor modified its statistical analysis plan (SAP) just one day before data unblinding, a move regulators characterized as scientifically unjustified and exploratory rather than pre-specified. The FDA concluded these changes compromised the integrity of the clinical evidence, ultimately finding that the benefit-risk profile for the therapy appeared unfavorable.

Investors suffered significant financial losses as the stock price reacted to the regulatory setbacks. On July 27, 2026, shares plummeted 64% following the release of the FDA briefing documents. Two days later, an advisory panel voted 9-3 that the available data failed to support the drug's efficacy, causing an additional 36% drop in market value. Shareholders who acquired securities during the class period have until September 28, 2026, to petition the court for lead plaintiff status in the case brought by Pomerantz LLP.