Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration

On October 14, 2026 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, reported 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.

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

"The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S.," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We appreciate the Agency’s guidance and look forward to a collaborative review process. We will continue supporting PFP as it prepares for a potential U.S. launch."

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders.

If tabelecleucel is approved, Atara would be eligible to receive a $31 million milestone payment under its commercialization agreement with Pierre Fabre Laboratories. Atara would also be eligible to receive significant double-digit tiered royalties on net sales and additional commercial sales milestones.

(Press release, Atara Biotherapeutics, OCT 14, 2026, View Source [SID1234673432])