deramiocel
Capricor Therapeutics Reports Positive Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy, Planning FDA Resubmission
Capricor Therapeutics; Deramiocel; Duchenne muscular dystrophy; HOPE-3 trial; Phase 3 clinical trial; FDA rejection; cardiac function preservation; upper limb function; clinical trial results; regulatory approval pathway
Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy
Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy
FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy
FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter
Capricor shares turn red as FDA plans deramiocel adcomm, likely the first under new commissioner
United States Food and Drug Administration, Capricor, deramiocel, Market, Review [Publication Type], Biologics License Application, first