Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date slated for August 31, 2025 Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified; late cycle meeting scheduled for June FDA has indicated intent to convene advisory committee... Read More