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Friday, June 26, 2026

Capricor: FDA panel to review Deramiocel BLA for Duchenne on July 29, PDUFA date Aug 22

 

Capricor: FDA panel to review Deramiocel BLA for Duchenne on July 29, 2026, PDUFA date August 22, 2026

  • 5-year HOPE-2 extension shows Deramiocel preserves skeletal and cardiac function in Duchenne muscular dystrophy patients.
  • HOPE-2 extension data support the ongoing Biologics License Application review for Deramiocel in Duchenne muscular dystrophy.
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