Atara biotherapeutics gets FDA alignment on tab-cel BLA resubmission path

Atara Biotherapeutics, Inc.

Type A meeting with FDA was productive; FDA agreed single-arm study with historical control could support future application.
Pierre Fabre to submit updated ALLELE study dataset with more patients and longer follow-up as part of resubmission.
Tabelecleucel is for R/R EBV+ PTLD post solid organ or hematopoietic cell transplant.
Company expects to provide further regulatory update in Q3 2026.

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