Atara To Face FDA Again In Jan.2026 - Will The Second Time Be The Charm For Tab-cel?

(RTTNews) - Atara Biotherapeutics Inc. (ATRA) is one step closer to securing approval for Tabelecleucel, a first-of-its-kind treatment for patients in the U.S.

Tabelecleucel, an innovative allogeneic T-cell immunotherapy, is proposed as monotherapy for the 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 FDA has accepted Atara's Biologics License Application (BLA) for Tabelecleucel, with a regulatory decision anticipated on January 10, 2026. This is the company's second attempt to gain approval after its initial application was rejected in January of this year due to issues in 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 early this month, which has been accepted and assigned the decision date.

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 has traded in a range of $5.01 to $18.70 in the last 1 year. The stock closed yesterday's trading at $12.26, down 5.84%.