UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On July 17, 2024, Atara Biotherapeutics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has accepted for priority review the Company’s Biologics License Application (“BLA”) for tabelecleucel (tab-cel®), an allogeneic, Epstein-Barr virus (EBV) specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The application has a Prescription Drug User Fee Act target action date of January 15, 2025. A copy of the Company’s press release, titled “Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease” is attached as Exhibit 99.1 hereto and is incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release, dated July 17, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ATARA BIOTHERAPEUTICS, INC. | ||||||
| Date: July 17, 2024 | By: | /s/ Eric Hyllengren | ||||
| Eric Hyllengren Chief Financial Officer (Duly Authorized Officer and Principal Financial and Accounting Officer) | ||||||