HOPE-3 Open-Label Extension: Upper Limb Function (PUL 2.0) ...

Miami, FL Jun 10, 2026 10:00 am EDT © 2026 Capricor Therapeutics, Inc. All Rights Reserved.

Capricor Therapeutics Second Quarter 2026 Financial Results and Corporate Update Conference Call Aug 13, 2026 4:30 pm EDT ...

-Improvements Seen in Multiple Cardiac and Skeletal Endpoints Demonstrating Stabilization of Cardiac and Skeletal Muscle Function Over 3 Years of Treatment- -Company on Track to Fully Submit Biologics ...

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 ...

– 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 ...

Deramiocel demonstrates durable skeletal and cardiac muscle benefit over five years in the HOPE-2 OLE study PUL 2.0 year-over-year decline attenuated to approximately 1 point Findings to be presented ...

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of ...

FDA and Capricor aligned on endpoints for HOPE-3 pivotal trial HOPE-3 pivotal trial completed; topline data expected mid-Q4 2025 to support BLA resubmission Company preparing to resubmit CRL response ...

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 ...

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, April 22, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today ...