Atara Biotherapeutics' Partner Pierre Fabre Pharmaceuticals Receives FDA Acceptance To Refile Biologics License Application For Tabelecleucel To Treat Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of 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.

The BLA has a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027.