CAPRICOR THERAPEUTICS, INC. 8-K

Summary

FDA advisory committee vote on Deramiocel. On 7/29/2026, the committee voted 3–9, with no abstentions, that available evidence did not support effectiveness for DMD-related cardiomyopathy. The vote addressed a narrower indication than Capricor proposed, was non-binding, and did not address Deramiocel’s overall benefit-risk profile; separate discussion of upper-limb function was directionally supportive of Phase 3 HOPE-3 evidence, including its primary PUL 2.0 endpoint.

Key Figures

• Advisory committee vote: 3 for, 9 against, 0 abstentions on whether evidence supported effectiveness for DMD-related cardiomyopathy. No approved treatment exists for this cardiac complication.

Investor Takeaways

• FDA action on the BLA remains targeted for 8/22/2026; the FDA will consider the committee recommendation and the complete administrative record.