HOPE-3 Open-Label Extension: Upper Limb Function (PUL 2.0) ...
Miami, FL Jun 10, 2026 10:00 am EDT Audio ...
Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance ...
SAN DIEGO, April 22, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today ...
– New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication – SAN DIEGO, Aug. 24, 2026 (GLOBE ...
Late-breaking presentation at MDA to feature Phase 3 HOPE-3 results supporting Deramiocel in Duchenne muscular dystrophy HOPE-3 clinical study report (CSR) submitted to the U.S. Food and Drug ...
Deramiocel Biologics License Application (BLA) under active FDA review HOPE-3 Phase 3 results published in The Lancet; primary endpoint of upper limb function achieved at p=0.029 Cash, cash ...
Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected to commence soon HOPE-3 Phase 3 trial met its primary endpoint (PUL v2.0; upper limb ...
LV end systolic volume, indexed (mL/m 2 )-2.4-5.1 LV end diastolic volume, indexed (mL/m 2)-5.7-10.0 *Baseline is referred to as start of HOPE-2 study, changes in medians are shown; 3-year timepoint ...
Deramiocel has the potential to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy BLA supported by positive pivotal HOPE-3 Phase 3 results, ...
SAN DIEGO, July 30, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today ...
Reduced progression of myocardial fibrosis measured by LGE on cardiac MRI (p=0.022) Significant improvement in LVEF versus placebo in patients with baseline cardiomyopathy (p=0.017) Global Statistical ...
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