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Atara issued a press release on January 16, 2025, announcing receipt of “a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLOTM (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.” The Company stated 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.”
Following this news, Atara’s stock price fell 40% on the same day.