secwatch.observer — SEC 8-K summary
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Issuer:     Autolus Therapeutics plc (AUTL)
CIK:        0001730463
Form:       8-K
Filed at:   2023-11-27T23:59:59+00:00
Accession:  0001730463-23-000115
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Autolus submits BLA to FDA for cell therapy obe-cel in r/r adult B-ALL
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- BLA for obecabtagene autoleucel (obe-cel) submitted to FDA for relapsed/refractory adult B-cell ALL.
- Submission based on Phase 2 FELIX study data presented at ASCO 2023; updated data at ASH December 2023.
- Autolus on track to submit Marketing Authorization Application to EMA in H1 2024.
- Obe-cel has FDA Orphan Drug, RMAT, and EMA PRIME designations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1730463/000173046323000115/0001730463-23-000115-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1730463/000173046323000115/autl-20231127.htm
  HTML page:      https://secwatch.observer/filing/0001730463-23-000115

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