Caesars Entertainment misses Q2 earnings expectations, shares edge lower
Investing.com -- Atara Biotherapeutics Inc (NASDAQ:ATRA) stock surged 7% after the U.S. Food and Drug Administration (FDA) accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel).
The BLA is for tab-cel as a monotherapy for adult and pediatric patients two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. Currently, there are no FDA-approved therapies for this indication.
The FDA granted Priority Review to the application with a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. The BLA 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 Chief Executive Officer of Atara.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The application is supported by data from more than 430 patients treated with tab-cel across multiple diseases, including the pivotal ALLELE study which demonstrated a statistically significant 48.8% Objective Response Rate.
The therapy has previously received Breakthrough Therapy Designation from the FDA for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease and has orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders.
Atara is working with Pierre Fabre Pharmaceuticals to prepare for the potential U.S. launch of the therapy.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.