regulatory
confidence high
sentiment positive
materiality 0.80
Atara resubmits tab-cel BLA to FDA for EBV+ PTLD; cash ~$22M, runway into Q1 2026
Atara Biotherapeutics, Inc.
- Atara resubmitted BLA to FDA for tabelecleucel (tab-cel) for EBV+ PTLD after CRL related to manufacturing observations.
- Pivotal ALLELE study showed 48.8% ORR (p<0.0001); no FDA-approved therapies in this setting.
- Cash, cash equivalents and short-term investments ~$22M as of June 30, 2025; cost cuts extend runway into Q1 2026.
- $40M milestone payment from Pierre Fabre due upon FDA approval; plus double-digit tiered royalties on net sales.
- Transitioning tab-cel clinical studies to Pierre Fabre; Atara maintains BLA sponsorship.
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