regulatory
confidence high
sentiment positive
materiality 0.70
Atara announces FDA agreement on tab-cel comparability; BLA submission planned Q2 2024
Atara Biotherapeutics, Inc.
- FDA and Atara aligned on analytical comparability between manufacturing process versions of tab-cel.
- Alignment allows pooling of pivotal clinical trial data from different process versions for BLA.
- Atara expects to submit tab-cel BLA in Q2 2024, enabling inclusion of Phase 3 ALLELE data.
- Company also advancing U.S. partnership discussions for tab-cel commercialization.