A securities class action has been filed against Atara Biotherapeutics, Inc. (ATRA) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Atara securities between May 20, 2024 through January 9, 2026. This case has been filed in the USDC – CDCA.
On January 12, 2026, Atara issued a press release “announcing that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the EBVALLO™ (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen.” Atara said that “[t]he CRL indicates that the FDA is unable to approve the EBVALLO™ BLA in its present form” because, according to the CRL, “the single arm ALLELE trial, which was previously confirmed by the FDA as adequate to support the BLA filing, is no longer considered to be adequate to provide evidence of effectiveness for accelerated approval. Furthermore, the FDA stated that the trial’s interpretability is confounded due to trial study design, conduct, and analysis.”
On this news, Atara’s stock price fell $7.79 per share, or 56.99%, to close at $5.88 per share on January 12, 2026.