The FDA has resumed review of Capricor Therapeutics’ previously rejected Duchenne muscular dystrophy cell therapy following the biotech’s submission of more clinical data, as well as the newly announced upcoming departure of Vinay Prasad, MD.
The agency has ‘lifted’ the complete response letter (CRL) that was issued for deramiocel in July 2025, Capricor said in a 10 March release, and an approval decision is now expected by 22August.
Capricor’s response to the rejection was a class 2 resubmission, a more substantial type of response that goes beyond minor clarifications of data or tweaks to the medicine’s planned label, according to the release.
The biotech’s response included topline data from a phase 3 trial that showed treatment with deramiocel improved upper limb function and left ventricle ejection fraction, a Capricor spokesperson told Pharma Press. These data were followed up by a clinical study report (CSR) in February at the agency’s request.