Capricor: Moving To 'Buy' Rating As New PDUFA Date Is Set For Deramiocel

Capricor Therapeutics is upgraded from 'Hold' to 'Buy' following FDA acceptance of the HOPE-3 clinical study report for Deramiocel in DMD cardiomyopathy. The FDA lifted the Complete Response Letter and set a PDUFA date of August 22, 2026, without requiring new studies, increasing regulatory clarity. Phase 3 HOPE-3 data showed Deramiocel slowed disease progression by 54% [PUL] and 91% [LVEF], with additional functional and fibrosis benefits.