FDA panel votes 9-3 against Capricor’s Deramiocel evidence in DMD cardiomyopathy

The non-binding advisory vote came ahead of an August 22, 2026, PDUFA action date, while committee discussion on upper limb function was described as supportive of Phase 3 HOPE-3 data.

Summary

verifying reliability

Terms & Concepts

No specialized terms available for this topic.