Atara receives FDA rejection, future uncertain
The bad news just keeps coming for Thousand Oaks-based Atara Biotherapeutics.
Nearly a year after the biotechnology company laid off 50% of its workforce after one rejection from the U.S. Food and Drug Administration, Atara received another one on Jan. 12.
In this notice, Atara, a company specializing in developing transformative therapies for patients with cancer and autoimmune diseases, said that the FDA was “unable to approve the Ebvallo Biologics License Application in its present form.”
Ebavllo, which is already approved in Europe, is used for transplant-related blood cancer, looking to help patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease who have received at least one prior therapy, including an anti-CD20-containing regimen.
Atara received the same notice on Jan. 16, 2025.
The BLA was resubmitted in 2025 after reaching alignment with the FDA on the acceptability of the resubmission criteria and fulfillment of the conditions as identified in the first Complete Response Letter. The reason for that first rejection was mainly due to a single deficiency regarding Good Manufacturing Practice, but had nothing to do with respect to the safety, efficacy or trial design.
In the newest notice, the FDA confirmed that the original Good Manufacturing Practice compliance issues were resolved and no additional safety issues were raised.
In a complete 180, however, the FDA said that Atara’s single-arm Allele trial, which it had previously said was adequate enough to support the 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 company said in a press release.
Shares of Atara have fallen more than 50% since the newest notice, with shares closing at $5.50 on Jan. 28, down about 60% since the start of the year.
Atara CEO Cokey Nguyen said the company is “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.”
She said that issues highlighted by the FDA were ones that they approved in previous communications with the agency.
“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 on the confirmation provided by the FDA,” Nguyen said.
“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.”
Unfortunately for Atara, neither time nor money is on their side at the moment.
The company currently only has cash, cash equivalents and short-term investments totaling about $8.5 million.
Atara has been doing everything to reduce costs, as in 2025 the company shedded about 90% of its workforce and transitioned all tab-cel activities and associated costs to Pierre Fabre Laboratories, including all regulatory, clinical and CMC responsibilities.
Moreover, in 2025, the company amended its lease at its research center in Thousand Oaks, reducing square footage and remaining lease liability by approximately 65%.
In December, Atara amended its commercialization agreement with Pierre Fabre Medicament to help mitigate the impact of the cost of rebuilding commercial inventory in the United States. That deal reduced Atara’s milestone payment from $60 million if Ebvallo’s BLA was approved to $31 million in exchange for the right to receive an additional $15 million potential milestone payment upon achieving a certain commercial milestone.
The company said that its roughly $8.5 million in assets is preliminary and has not yet been audited.
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