Abeona Therapeutics announces FDA acceptance of BLA resubmission of pz-cel

Abeona Therapeutics (ABEO) announced that the U.S. Food and Drug Administration, FDA, has accepted for review Abeona’s resubmission of its Biologics License Application, BLA, for prademagene zamikeracel, pz-cel, its investigational autologous cell-based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa, RDEB. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025. “The FDA acceptance of our BLA resubmission moves us one step closer to providing pz-cel as a differentiated treatment option to address the persistent unmet needs of people with RDEB in the U.S.,” said Vish Seshadri, Chief Executive Officer of Abeona. “We look forward to continuing to work with the FDA to finalize the review of the pz-cel application.”