Abeona Therapeutics completes Pz-cel BLA resubmission to U.S. FDA

Abeona Therapeutics (ABEO) announced that the Company has resubmitted its Biologics License Application, BLA, to the U.S. Food and Drug Administration, FDA, for prademagene zamikeracel, its investigational autologous cell-based gene therapy, as a potential new treatment for patients with recessive dystrophic epidermolysis bullosa, RDEB. “We have worked closely with the FDA in preparing for the pz-cel BLA resubmission and thank the Agency for their ongoing guidance,” said Vish Seshadri, Chief Executive Officer of Abeona. “We have incorporated the Agency’s feedback and are confident that our resubmission package addresses all the Chemistry Manufacturing and Controls items identified in the Complete Response Letter, including observations from the completed Pre-License Inspection of our manufacturing facility. Upon acceptance of the BLA, we look forward to assisting the FDA in the completion of its review.”