Atara Biotherapeutics Inc (NASDAQ:ATRA) saw its stock jump 7% following the U.S. Food and Drug Administration’s acceptance of its Biologics License Application (BLA) for tabelecleucel (tab-cel).
The BLA seeks approval for tab-cel as a standalone treatment for adults and children aged two and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have undergone at least one prior therapy. There are currently no FDA-approved treatments for this condition.
The FDA has granted Priority Review to the submission, with a Prescription Drug User Fee Act (PDUFA) target decision date set for January 10, 2026. The application was classified as a Class 2 Resubmission.
“The acceptance of the tab-cel resubmission moves us one step closer towards making this first-of-its-kind treatment available to patients in the U.S.,” said Cokey Nguyen, President and CEO of Atara.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy engineered to target and destroy EBV-infected cells. The application includes data from over 430 patients treated with tab-cel across various diseases, notably the pivotal ALLELE study, which showed a statistically significant Objective Response Rate of 48.8%.
Previously, the therapy was granted Breakthrough Therapy Designation by the FDA for rituximab-refractory EBV-associated lymphoproliferative disease and holds orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders.
Atara is collaborating with Pierre Fabre Pharmaceuticals in preparation for a potential U.S. launch of the treatment.
Atara Biotherapeutics stock price
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