The legal action, Nkamga v. Capricor Therapeutics, Inc., centers on the period between December 17, 2025, and July 26, 2026. Allegations surfaced after the FDA released briefing documents ahead of a July 2026 advisory committee meeting. Regulators noted that Capricor modified its statistical analysis plan just one day before data was unblinded without prior agency agreement. The FDA characterized these post-study changes as exploratory and criticized the lack of scientific justification for the methodology, ultimately questioning the benefit-risk profile of the drug.

Following the disclosure, Capricor shares dropped $12.70—a 64% decline—to close at $7.00 on July 27, 2026. The case is currently pending in the U.S. District Court for the Southern District of California. Shareholders seeking to participate or discuss their options can contact Kahn Swick & Foti, LLC or visit the ClaimsFiler portal.