Capricor Deramiocel FDA Setback Securities Class Actions

Paragon Therapeutics, a biotechnology company developing Deramiocel for Duchenne muscular dystrophy, faced a major regulatory setback. On July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting, raising concerns about post-hoc changes to the statistical analysis plan and stating the data did not provide substantial evidence of effectiveness. The stock dropped 64% to $7.00. On July 29, the advisory committee voted 9-3 that available evidence did not support Deramiocel's effectiveness for DMD-associated cardiomyopathy, causing another 36% drop to $4.19. Subsequently, multiple law firms filed securities class actions alleging Capricor made false and misleading statements about the clinical data and regulatory pathway. The class period is December 17, 2025 to July 26, 2026, with a lead plaintiff deadline of September 28, 2026. Capricor remains committed to working with the FDA toward potential approval ahead of the August 22, 2026 PDUFA date.