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A lawsuit has been filed on behalf of investors who purchased securities of Atara during the period from May 20, 2024 through January 9, 2026 (the “Class Period”). The complaint alleges that manufacturing issues and deficiencies inherent in the ALLELE study made it unlikely that the U.S. Food and Drug Administration would approve the tabelecleucel Biologics License Application (BLA). It further alleges that tabelecleucel’s regulatory prospects were overstated and that the manufacturing issues increased the risk of regulatory scrutiny and jeopardized ongoing clinical trials. The filing also claims that these developments were likely to have a significant negative impact on Atara’s business and financial condition.
January 16, 2025: Atara announced it had received a Complete Response Letter (CRL) regarding the tabelecleucel BLA. The company stated that the CRL “was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO.” Following the announcement, Atara’s share price fell by $5.33 per share (about 40.5%), from $13.16 on January 15, 2025 to close at $7.83 on January 16, 2025.
January 21, 2025: Atara later announced that the FDA placed a clinical hold on its active Investigational New Drug (IND) applications. The company attributed the hold 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 stock declined by $0.52 per share (about 8%), from $6.57 on January 17, 2025 to close at $6.05 on January 21, 2025.
January 12, 2026: Atara reported that the FDA issued another CRL regarding the tabelecleucel BLA, which the company had resubmitted in July 2025. Atara said the CRL indicated that the FDA was “unable to approve the EBVALLO BLA in its present form,” citing that the “single arm ALLELE trial . . . is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval,” and that the trial’s interpretability is “confounded due to trial study design, conduct, and analysis.” After the announcement, Atara shares fell by $7.79 per share (about 57%), from $13.67 on January 9, 2026 to close at $5.88 on January 12, 2026.
The lawsuit alleges that the manufacturing issues and study-related deficiencies were likely to have contributed to the FDA’s inability to approve the BLA in the cited CRLs. It also asserts that the manufacturing problems increased regulatory scrutiny and jeopardized Atara’s ongoing clinical trials, with the overall developments expected to negatively affect the company’s business and financial condition.
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