Atara Biotherapeutics Resubmits Tabelecleucel BLA to FDA, Eyes $31 Million Milestone (ATRA)

Atara Biotherapeutics (ATRA) said September 30, 2026, that partner Pierre Fabre Pharmaceuticals resubmitted the Biologics License Application for tabelecleucel to the U.S. Food and Drug Administration. ATRA shares rose 9.69% to $8.83 in premarket trading after closing at $8.05 on September 29, down 3.82%. The investigational allogeneic Epstein-Barr virus-specific T-cell immunotherapy targets relapsed or refractory EBV-positive post-transplant lymphoproliferative disease. The resubmission adds patients and longer follow-up from the pivotal Phase 3 ALLELE study in adults and children aged 2 and older after solid organ or hematopoietic cell transplant, plus expanded access, separate study and European commercial data. Atara is eligible for a $31 million milestone payment upon FDA approval, along with tiered double-digit royalties on net sales and additional commercial milestones.