FDA lifts clinical hold on Atara's EBVALLO program; Type A meeting granted

Atara Biotherapeutics, Inc.

FDA lifted clinical hold on EBVALLO (tabelecleucel) IND applications, allowing resumption of Phase 3 ALLELE and Phase 2 label-expansion studies.
FDA granted a Type A meeting to discuss path forward for BLA resubmission after January 2025 CRL citing GMP issues at third-party facility.
Strategic option evaluation temporarily paused pending FDA clarity on BLA resubmission timing.
Clinical hold directly linked to GMP compliance issues identified during pre-license inspection; resolved with supplemental finished drug product data.

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