---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-180371"
form_type: "8-K"
ticker: "ATRA"
cik: "0001604464"
company_name: "Atara Biotherapeutics, Inc."
filed_at: "2024-07-17T23:59:59+00:00"
generated_at: "2026-05-31T20:14:07.406359+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Atara Biotherapeutics' tab-cel BLA accepted for priority review by FDA; PDUFA Jan 15, 2025

## Summary
- BLA for tabelecleucel (tab-cel) accepted for priority review to treat EBV+ PTLD in patients ≥2 years with ≥1 prior therapy.
- PDUFA target action date set for January 15, 2025; no FDA-approved therapy currently exists for this indication.
- BLA acceptance triggers $20M milestone payment from Pierre Fabre; up to $60M additional if FDA approves.
- Supported by ALLELE study data showing 48.8% objective response rate (p<0.0001) and favorable safety profile.
- Tab-cel already approved as Ebvallo in EU, UK, and Switzerland for relapsed/refractory EBV+ PTLD.

## SEC filing metadata
- accession: 0001193125-24-180371
- form_type: 8-K
- ticker: ATRA
- cik: 0001604464
- company_name: Atara Biotherapeutics, Inc.
- filed_at: 2024-07-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1604464/000119312524180371/0001193125-24-180371-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1604464/000119312524180371/d868530d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-180371
- JSON: https://secwatch.observer/filing/0001193125-24-180371.json
- Plain text: https://secwatch.observer/filing/0001193125-24-180371.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.