ITEM 8.01 Other Events.
On January 4, 2021, Atara Biotherapeutics, Inc. (the "Company") announced that
it had not yet initiated the Biologics License Application (the "BLA")
submission for tab-cel® (tabelecleucel), currently in Phase 3 development for
Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+
PTLD). The Company is awaiting a procedural decision from the U.S. Food and Drug
Administration (the "FDA") related to how certain historical, non-pivotal data
should be presented in the BLA submission. The Company believes that it remains
on track to complete the BLA submission in the third quarter of 2021.
Forward-Looking Statements
This current report contains forward-looking statements, including, without
limitation, statements regarding tab-cel®, including the Company's discussions
with, and potential decisions by, the FDA regarding the BLA submission for EBV+
patients with PTLD, the timing and results of additional clinical data, and the
timing of, and the Company's plans for, initiation and completion of the BLA.
Because such statements deal with future events and are based on the Company's
current expectations, they are subject to various risks and uncertainties and
actual results, performance or achievements of the Company could differ
materially from those described in or implied by the statements in this current
report. These forward-looking statements are subject to risks and uncertainties,
including those discussed in the Company's filings with the Securities and
Exchange Commission (the "SEC"), including in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" sections of the Company's most recently filed periodic reports on
Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated
by reference therein. Except as otherwise required by law, the Company disclaims
any intention or obligation to update or revise any forward-looking statements,
which speak only as of the date hereof, whether as a result of new information,
future events or circumstances or otherwise.
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