LOS ANGELES–(BUSINESS WIRE)–The Law Offices of Frank R. Cruz announces an investigation of Atara Biotherapeutics, Inc. (“Atara” or the “Company”) (NASDAQ: ATRA) on behalf of investors concerning the Company’s possible violations of federal securities laws.
IF YOU ARE AN INVESTOR WHO LOST MONEY ON ATARA BIOTHERAPEUTICS, INC. (ATRA), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS.
What Is The Investigation About?
On January 16, 2025, Atara disclosed that it had received a Complete Response Letter (“CRL”) from the FDA regarding the Biologics License Application (“BLA”) of the Company’s Epstein-Barr treatment, tabelecleucel (also referred to as EBVALLO), and that the application would not be approved in its current form, 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, Atara’s stock price fell $5.33, or 40.5%, to close at $7.83 per share on January 16, 2025, thereby injuring investors.
Then, on January 21, Atara disclosed that the FDA had “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, Atara’s stock price fell $0.52, or 7.9%, to close at $6.05 per share on January 21, 2025.
Finally, on January 12, 2026, Atara disclosed that the FDA had issued another CRL regarding the resubmitted tabelecleucel BLA 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, Atara’s stock price fell $7.79, or 56.99%, to close at $5.88 per share on January 12, 2026, thereby injuring investors further.
Contact Us To Participate or Learn More:
If you purchased Atara securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us:
The Law Offices of Frank R. Cruz,
2121 Avenue of the Stars, Suite 800,
Century City, California 90067
Call us at: 310-914-5007
Email us at: [email protected]
Visit our website at: www.frankcruzlaw.com.
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If you inquire by email, please include your mailing address, telephone number, and number of shares purchased.
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Contacts
Contact Us:
The Law Offices of Frank R. Cruz, Los Angeles
Frank R. Cruz
310-914-5007
[email protected]
www.frankcruzlaw.com
