Atara Biotherapeutics Inc. (ATRA) will know on January 10, 2026, whether its second attempt to secure FDA approval for Tabelecleucel will succeed.Tabelecleucel, an innovative allogeneic T-cell immunotherapy, is proposed as monotherapy for the treatment of adult and pediatric patients aged two years and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.Post-transplant lymphoproliferative disease (PTLD) is a type of cancer that can develop in people who have received a bone marrow or solid organ transplant. Studies show that in approximately half of PTLD patients, a common virus called Epstein-Barr virus (EBV) is the cause of the disease. This is referred to as Epstein-Barr virus positive (EBV+) PTLD.The U.S. regulatory agency declined to approve Tabelecleucel in January of 2025, due to issues at a third-party manufacturing facility. Addressing the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter, the company resubmitted its BLA for Tabelecleucel this July and now awaits the decision.Tabelecleucel, or Tab-cel in short, under the brand name Ebvallo, is approved in the European Union, the United Kingdom, and Switzerland as a monotherapy for the treatment of adult and pediatric patients aged two and older with relapsed or refractory EBV+ PTLD, who have received at least one previous therapy. Ebvallo has been marketed in Europe since 2022, in the UK since 2023, and in Switzerland since 2024.ATRA closed Monday’s (Dec.29, 2025) trading at $17.99, up 4.17%.