Capricor Hit With Multiple Securities Lawsuits After FDA Called Its Analyses Post‑Hoc

Overview

• The FDA’s July 27, 2026 briefing said Capricor changed its pre‑specified statistical analysis plan and that the final SAP was not submitted for review, describing analyses based on later SAP versions as post‑hoc and exploratory.
• An FDA advisory committee voted 9‑3 on July 29, 2026 that the available evidence did not support Deramiocel’s efficacy for DMD‑associated cardiomyopathy.
• Capricor’s shares plunged about 64% on the July 27 briefing and fell further after the July 29 advisory committee meeting, moves plaintiffs cite as investor harm.
• Multiple securities class actions filed in the Southern District of California allege Capricor failed to disclose the SAP changes and related regulatory risks, and they assert that positive public statements were materially misleading.
• The company disputes the FDA characterization and says it engaged with regulators, while the litigation remains at the pre‑certification stage with competing firms seeking a lead plaintiff before September 28, 2026.