Capricor Therapeutics Announces Positive Phase 3 HOPE-3 Results for Deramiocel in Duchenne Muscular Dystrophy

CAPRICOR THERAPEUTICS, INC.

Primary endpoint PUL v2.0 met with 54% slowing of progression (p=0.029) in 105 evaluable patients.
Key secondary cardiac endpoint LVEF showed 91% slowing of decline (p=0.041) in 83 evaluable patients.
Study enrolled 106 participants (average age 15) across 20 U.S. sites; over 75% had diagnosed cardiomyopathy.
Deramiocel maintained a favorable safety and tolerability profile consistent with prior clinical experience.
Company plans to submit response to Complete Response Letter incorporating HOPE-3 data following prior FDA alignment.

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