Atara down 41% on Ebvallo CRL

17 January 2025

T-cell immunotherapy company Atara Biotherapeutics (Nasdaq: ATRA) closed 41% lower on Friday.

Atara earlier announced receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its Ebvallo (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for patients aged 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.

According to Atara, the CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for Ebvallo. 

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