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Atara Biotherapeutics Says FDA Lifts Clinical Hold on Ebvallo Investigational New Drug Applications
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Atara Biotherapeutics Says FDA Lifts Clinical Hold on Ebvallo Investigational New Drug Applications
May 26, 2025 1:47 AM

05:45 AM EDT, 05/06/2025 (MT Newswires) -- Atara Biotherapeutics ( ATRA ) said late Monday that the US Food and Drug Administration lifted the clinical hold on its investigational new drug applications for the Ebvallo program after reviewing supplemental data on finished drug product.

The move allows the company to restart a phase 3 clinical study for patients with Epstein-Barr Virus-associated post-transplant lymphoproliferative disease and the phase 2 label-expansion multi-group clinical study.

Atara said it has temporarily paused its strategic option evaluation process pending clarity with the FDA on timing of the resubmission of the Ebvallo BLA.

"It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated," the company said.

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