Capricor – Duchenne cell therapy BLA pathway shifts after FDA open-label results

Capricor Therapeutics’ deramiocel program is getting renewed attention after the company reported open-label extension (OLE) data linked to its Duchenne muscular dystrophy (DMD) filing pathway following an FDA advisory setback. The new OLE readout pertains to deramiocel in DMD cardiomyopathy patients and supports Capricor’s plan to seek FDA review of additional data.