Capricor publishes advisory committee presentation on deramiocel clinical data in Duchenne muscular dystrophy

• Capricor outlined Phase 3 HOPE-3 data for deramiocel in Duchenne muscular dystrophy, citing a statistically significant PUL 2.0 total score benefit.
• Primary endpoint showed a 4.55% treatment difference on percent change, p=0.029 (MMRM); sensitivity analysis on absolute change was 1.1, p=0.05.
• Cardiomyopathy subgroup with evaluable MRI LVEF (n=64) showed a 2.9% LVEF difference, p=0.035 (ranked ANCOVA); p=0.026 (Wilcoxon).
• Materials highlighted protocol and statistical analysis plan revisions tied to FDA feedback; SAP 3.0 was finalized before database lock and unblinding.
• Program summary cited more than 200 DMD patients across trials, with generally favorable tolerability and no serious safety issues highlighted in earlier studies.

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