Company: ATRA
Filing Date: 2025-05-06
Form Type: 8-K
Source: 0001193125-25-113811
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Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-05-06
Form: 8-K
Item: Item 8.01
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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.