Capricor Faces Shareholder Investigation After Deramiocel FDA Setback

The regulatory fallout centers on discrepancies between internal company statements and the FDA’s assessment of Deramiocel. As recently as March 2026, CEO Linda Marbán assured investors that the FDA had not identified any material review issues. She further maintained in May 2025 that the decision to convene an advisory committee was unrelated to any weaknesses in the company's application.

Contradicting these claims, the FDA briefing documents released ahead of a July 29 advisory committee meeting noted that Deramiocel failed to demonstrate a statistically significant benefit on its primary cardiac endpoint. Reviewers also highlighted that the statistical analysis plan had been modified after the data was unblinded, raising questions about the validity of the results. Investors who sustained losses following these disclosures are now being evaluated for potential securities law claims, with the investigation focusing on whether prior corporate statements regarding the therapy's effectiveness were materially false or misleading.