NasdaqCM:CAPRBiotechs
Does FDA’s HOPE-3 Data Request Clarify Deramiocel’s Regulatory Path For Capricor Therapeutics (CAPR)?
Capricor Therapeutics recently reported that the FDA, after reviewing topline Phase 3 HOPE-3 data for Deramiocel in Duchenne muscular dystrophy, has issued a request for the full clinical study report and supporting data to address a prior Complete Response Letter, without asking for new clinical trials or patient data.
The company aims to submit the HOPE-3 report in February 2026, a step that could clarify the regulatory path for this first-in-class cell therapy candidate with multiple...