(RTTNews) - Capricor Therapeutics, Inc. (CAPR) on Wednesday announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel for the treatment of Duchenne muscular dystrophy (DMD). The study met its primary endpoint, sending the company's shares up more than 14% in pre-market trading.
The trial randomized participants to receive either Deramiocel or a placebo over a 12-month period. Results showed clinically meaningful and statistically significant skeletal and cardiac benefits, supporting Deramiocel as a potential first-in-class therapy targeting Duchenne cardiomyopathy, the leading cause of mortality in DMD. The therapy maintained a favorable safety and tolerability profile, consistent with previous clinical experience.
Capricor plans to submit its response to the Complete Response Letter for Deramiocel's Biologics License Application (BLA) received in July, incorporating the HOPE-3 data, following prior alignment with the U.S. Food and Drug Administration.
Capricor Therapeutics shares had closed at $6.36, down 4.36% on Tuesday.
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