Abeona Late April PDUFA Date for Epidermolysis Bullosa

 Abeona Therapeutics Inc. (Nasdaq: ABEO) today 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.

https://www.globenewswire.com/news-release/2024/11/12/2978973/0/en/Abeona-Therapeutics-Announces-FDA-Acceptance-of-BLA-Resubmission-of-Pz-cel-for-the-Treatment-of-Recessive-Dystrophic-Epidermolysis-Bullosa.html