Capricor provides regulatory update on Deramiocel for Duchenne

Capricor Therapeutics, which received early funding from CureDuchenne, said the FDA has requested the full clinical study report from their latest clinical trial, the HOPE-3 trial.  Positive topline results from the HOPE-3 trial was reported in late 2025, and Capricor plans to submit the additional materials requested in February 2026.  The company expects these materials will address outstanding items in the Complete Response Letter (CRL) the FDA had previously issued, and support continued review of Deramiocel for approval for Duchenne.   

Link to press release HERE