Atara Biotherapeutics Inc., in collaboration with Pierre Fabre Pharmaceuticals Inc. (PFP), announced that the Biologics License Application (BLA) for tabelecleucel, a novel allogeneic T-cell therapy, has been transferred to PFP and is currently under Priority Review by the U.S. Food and Drug Administration (FDA). The BLA, accepted by the FDA on July 23, 2025, has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. If approved, tabelecleucel would be indicated as monotherapy for adult and pediatric patients two years of age and older with Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) who have received at least one prior therapy. Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide.