UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
On May 5, 2025, Atara Biotherapeutics, Inc. (the “Company”) issued a press release titled “Atara Biotherapeutics Provides Regulatory Updates on EBVALLO™ (tabelecleucel)” announcing that the U.S. Food and Drug Administration (“FDA”) lifted the clinical hold on the Company’s active Investigational New Drug applications for the EBVALLO™ (tabelecleucel) program that was placed in January 2025. The press release also announced that the FDA granted the Company a Type A meeting to discuss the plan to address the issues raised by the FDA in the Complete Response Letter issued in January 2025. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press release, dated May 5, 2025 | |
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: May 6, 2025 | By: | /s/ AnhCo Thieu Nguyen | ||||
AnhCo Thieu Nguyen President and Chief Executive Officer (Duly Authorized Officer and Principal Executive Officer) |