UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Atara Biotherapeutics, Inc. | ||
| By: | /s/ Amar Murugan | |
| Amar Murugan | ||
| Senior Vice President, General Counsel | ||
Dated: January 4, 2021