secwatch.observer — SEC 8-K summary
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Issuer:     Atara Biotherapeutics, Inc. (ATRA)
CIK:        0001604464
Form:       8-K
Filed at:   2024-07-17T23:59:59+00:00
Accession:  0001193125-24-180371
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1604464/000119312524180371/0001193125-24-180371-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1604464/000119312524180371/d868530d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-180371

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer