FDA Requests HOPE-3 Clinical Study Report for Deramiocel BLA in DMD Cardiomyopathy Isabella Ciccone, MPH

Published Date: 23 Jan 2026

The FDA requested the full data from the phase 3 HOPE-3 study as part of its review of the biologics license application for deramiocel, which Capricor plans to submit in February 2026.

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