On January 12, 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 the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the EBVALLO (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for 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 including an anti-CD20 containing regimen.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The CRL indicates that the FDA is unable to approve the EBVALLO BLA in its present form. The BLA was resubmitted in 2025 after reaching alignment with the FDA on the acceptability of the resubmission criteria and fulfilment of the conditions as identified in the first Complete Response Letter dated 15 January 2025 (First CRL). As we previously disclosed, in the First CRL, the FDA identified a single deficiency regarding Good Manufacturing Practice (GMP) compliance and did not raise any concerns with respect to the safety, efficacy or trial design.
In the current CRL, received after market close on 9 January 2026, the FDA confirmed that the GMP compliance issues had been satisfactorily resolved, and importantly, no safety issues were raised. However, in a complete reversal of position by the FDA, the CRL claims that the single arm ALLELE trial, which was previously confirmed by the FDA as adequate to support the BLA filing, is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval. Furthermore, the FDA stated that the trial’s interpretability is confounded due to trial study design, conduct, and analysis.
The FDA’s new position is contrary to the FDA’s prior guidance to Atara, the FDA’s alignment with Atara on the clinical trial data set, and the acceptance of the trial design as a single arm study as relevant for this patient population at BLA submission. This prior alignment had been reached by Atara and the FDA through multiple, documented meetings held over the past five plus years.
In November 2025, Atara transferred the BLA to Pierre Fabre Pharmaceuticals (PFP), Inc., the U.S. pharmaceutical subsidiary of Pierre Fabre Laboratories. As a first step towards resolution, PFP intends to request a Type A meeting and expects it to be granted within 45 days. PFP and Atara plan to urgently interact with the FDA to find a path forward for the timely accelerated approval of EBVALLO without which patients with EBV+ PTLD have extremely limited treatment options and a life expectancy often measured in weeks to months.
"We are surprised and disappointed by this FDA decision for EBV+ PTLD patients who have a significant unmet need, highlighted by tabelecleucel’s Orphan Drug designation and by the granting of Breakthrough status at the time we submitted the ALLELE primary data," said Cokey Nguyen, President and Chief Executive Officer of Atara. "The issues highlighted in the CRL were issues Atara and the FDA aligned on in previous reviews or communications. We had aligned with the agency to accept an Accelerated Approval and to perform a post marketing confirmatory study to support full approval. We proceeded with the BLA submission on this basis and continued all remediation efforts after the resubmission in 2025, in full reliance of the confirmation provided by the FDA. We strongly believe that tabelecleucel can bring substantial benefit to post-transplant lymphoproliferative disease patients, and look forward to addressing the concerns of the FDA clinical review team newly in place alongside our partners."
Corporate and Financial Updates
In December 2025, Atara amended the commercialization agreement with Pierre Fabre Medicament (PFM) to, among other things, mitigate the impact of the cost of rebuilding commercial inventory in the United States. Under the terms of the amendment, Atara agreed to reduce the milestone payment due upon BLA approval to $31 million in exchange for the right to receive an additional $15 million potential milestone payment upon achieving a certain commercial milestone.
Cash, cash equivalents and short-term investments as of December 31, 2025, totaled approximately $8.5 million.
In 2025, Atara implemented significant operational efficiencies, including an approximately 90% reduction in headcount year over year, and transitioned substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories including all regulatory, clinical and CMC responsibilities.
Additionally, in November 2025, we amended our Atara Research Center (ARC) lease agreement reducing our square footage and remaining lease liability by approximately 65%.
This estimate of our cash, cash equivalents, short-term investments and accounts receivable as of December 31, 2025, is preliminary, and has not been audited and is subject to change upon completion of our financial statement closing procedures. Our independent registered public accounting firm has not audited or performed any procedures with respect to this estimate. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of December 31, 2025.
(Press release, Atara Biotherapeutics, JAN 12, 2026, View Source [SID1234662053])