Atara Biotherapeutics, Inc.
Case Overview
59 Days Left to Seek Lead Plaintiff
| Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 05/22/2026 |
| Status: | Status: Investigating |
| Company Name: | Company Name: Atara Biotherapeutics, Inc. |
| Court: | Court: Central District of California |
| Case Number: | Case Number: 2:26cv03083 |
| Class Period: | Class Period: 05/20/2024 - 01/09/2026 |
| Ticker: | Ticker: ATRA |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Atara Biotherapeutics, Inc. (“Atara” or the “Company”) (NASDAQ:ATRA) securities during the period of May 20, 2024 through January 9, 2026, inclusive (“the Class Period”).
The lawsuit alleges that (i) certain manufacturing issues, as well as deficiencies inherent in the ALLELE study, made it unlikely that the FDA would approve the tabelecleucel BLA; (ii) accordingly, tabelecleucel's regulatory prospects were overstated; (iii) the aforementioned manufacturing issues also subjected Atara to a heightened risk of regulatory scrutiny, as well as jeopardized its ongoing clinical trials; and (iv) all the foregoing was likely to have a significant negative impact on Atara's business and financial condition.
On January 16, 2025, Atara issued a press release announcing its receipt of a Complete Response Letter (“CRL”) regarding the tabelecleucel BLA, stating that “[t]he CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO.” On this news, the price of Atara shares declined by $5.33 per share, or approximately 40.5%, from $13.16 per share on January 15, 2025 to close at $7.83 on January 16, 2025.
On January 21, 2025, Atara issued a press release announcing “that the [FDA] has placed a clinical hold on Atara’s active Investigational New Drug (IND) applications” due to “inadequately addressed GMP [good manufacturing practice] compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the [CRL]” issued in connection with the tabelecleucel BLA. On this news, the price of Atara shares declined by $0.52 per share, or approximately 8%, from $6.57 per share on January 17, 2025 to close at $6.05 on January 21, 2025.
On January 12, 2026, Atara issued a press release announcing that the FDA had issued another CRL regarding the tabelecleucel BLA-which the Company had resubmitted to the FDA in July 2025-stating that “[t]he CRL indicates that the FDA is unable to approve the EBVALLO BLA in its present form” because “the single arm ALLELE trial . . . is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval” and “the trial’s interpretability is confounded due to trial study design, conduct, and analysis.” On this news, the price of Atara shares declined by $7.79 per share, or approximately 57%, from $13.67 per share on January 9, 2026 to close at $5.88 on January 12, 2026.
The lawsuit alleges that (i) certain manufacturing issues, as well as deficiencies inherent in the ALLELE study, made it unlikely that the FDA would approve the tabelecleucel BLA; (ii) accordingly, tabelecleucel's regulatory prospects were overstated; (iii) the aforementioned manufacturing issues also subjected Atara to a heightened risk of regulatory scrutiny, as well as jeopardized its ongoing clinical trials; and (iv) all the foregoing was likely to have a significant negative impact on Atara's business and financial condition.
On January 16, 2025, Atara issued a press release announcing its receipt of a Complete Response Letter (“CRL”) regarding the tabelecleucel BLA, stating that “[t]he CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO.” On this news, the price of Atara shares declined by $5.33 per share, or approximately 40.5%, from $13.16 per share on January 15, 2025 to close at $7.83 on January 16, 2025.
On January 21, 2025, Atara issued a press release announcing “that the [FDA] has placed a clinical hold on Atara’s active Investigational New Drug (IND) applications” due to “inadequately addressed GMP [good manufacturing practice] compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the [CRL]” issued in connection with the tabelecleucel BLA. On this news, the price of Atara shares declined by $0.52 per share, or approximately 8%, from $6.57 per share on January 17, 2025 to close at $6.05 on January 21, 2025.
On January 12, 2026, Atara issued a press release announcing that the FDA had issued another CRL regarding the tabelecleucel BLA-which the Company had resubmitted to the FDA in July 2025-stating that “[t]he CRL indicates that the FDA is unable to approve the EBVALLO BLA in its present form” because “the single arm ALLELE trial . . . is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval” and “the trial’s interpretability is confounded due to trial study design, conduct, and analysis.” On this news, the price of Atara shares declined by $7.79 per share, or approximately 57%, from $13.67 per share on January 9, 2026 to close at $5.88 on January 12, 2026.