ATRA Stock Nearly Halves In Value After FDA Refuses Approval For Immunotherapy: Retail Sees ‘Big Fight Back’

• This is the second time that the FDA has refused to approve EBVALLO.
• Atara said in a statement on Monday that the FDA’s new position is “contrary” to its prior alignment with the company on the trial design.
• Atara had transferred its application seeking approval for EBVALLO to a U.S. pharma unit of Pierre Fabre Laboratories in November.

Shares of Atara Biotherapeutics, Inc. (ATRA) slumped 53% on Monday after the U.S. Food and Drug Administration refused approval for its immunotherapy EBVALLO in treating patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Epstein-Barr Virus (EBV)-positive Post-Transplant Lymphoproliferative Disorder (PTLD) is a serious, often life-threatening complication after organ or stem cell transplantation, characterized by uncontrolled growth of EBV-infected B-cells due to suppressed immunity, ranging from mononucleosis-like illness to aggressive lymphoma.

The FDA said in a letter to the company that it is unable to approve its EBVALLO application in present form, stating that the trial conducted by the company is not adequate to provide evidence of effectiveness for accelerated approval. The authority also stated that the trial’s interpretability is confounded due to trial study design, conduct, and analysis.

Back-To-Back Rejection

This is the second time that the FDA has refused to approve EBVALLO. The company resubmitted its application in 2025 after it was rejected the first time due to a concern with manufacturing.

Atara said in a statement on Monday that the FDA’s new position is “contrary” to its prior alignment with the company on the trial design. “This prior alignment had been reached by Atara and the FDA through multiple, documented meetings held over the past five plus years,” it said.  

Atara had transferred its application seeking approval for EBVALLO to a U.S. pharma unit of Pierre Fabre Laboratories in November. Pierre will now seek a meeting with the FDA, which is expected to be granted within 45 days. The company said that it intends to urgently interact with FDA to find a path forward for EBVALLO approval with Pierre.

Company’s Reaction

Atara CEO Cokey Nguyen said that the company is “surprised and disappointed” by the FDA decision.

“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,” the CEO said.

Atara ended 2025 with cash, cash equivalents and short-term investments of $8.5 million after trimming down workforce by about 90% year-over-year and transitioning almost all activities and costs pertaining to EBVALLO to Pierre Fabre laboratories.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around ATRA stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.

A Stocktwits user expressed disappointment over the news.

Yet another said that they added more shares of the company. “I am already sensing a big fight back,” they said.

ATRA stock has dropped 60% over the past 12 months. 

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