Clinical hold follows CRL for Atara

T-cell immunotherapy company Atara Biotherapeutics (Nasdaq: ATRA) closed 8% lower on Tuesday, having lost 41% of its stock market value on Friday.

The earlier share sell-off was caused by Atara’s 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.

Tuesday’s further stock market slump came with the news that the FDA has placed a clinical hold on Atara’s Ebvallo (tabelecleucel) and ATA3219 studies linked to the CRL.