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Tuesday, July 16, 2019

Atara to initiate U.S. application for tab-cel in H2 2020

Based on its recent dialogue with the FDA, Atara Biotherapeutics (NASDAQ:ATRAannounces that it expects to initiate its Biologics License Application (BLA) seeking approval for T-cell immunotherapy tab-cel (tabelecleucel) for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in H2 2020.
Update: Shares are down 13% on average volume as investors react to the pivot on the filing. Management originally forecasted that an application in Europe would be first up, expected in 2020.

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