secwatch.observer — SEC 8-K summary
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Issuer:     Autolus Therapeutics plc (AUTL)
CIK:        0001730463
Form:       8-K
Filed at:   2024-01-26T23:59:59+00:00
Accession:  0001730463-24-000007
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Autolus Therapeutics announces FDA acceptance of BLA for obe-cel; PDUFA date Nov 16, 2024
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- FDA accepted BLA for obe-cel in relapsed/refractory Adult B-ALL; PDUFA target action date November 16, 2024.
- No advisory committee meeting is currently planned for this application.
- BLA submission based on Phase 2 FELIX study data presented at ASCO 2023 and ASH 2023.
- Company plans to submit Marketing Authorization Application to EMA in H1 2024.
- Obe-cel has Orphan Drug, RMAT (FDA), and PRIME (EMA) designations.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1730463/000173046324000007/0001730463-24-000007-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1730463/000173046324000007/autl-20240122.htm
  HTML page:      https://secwatch.observer/filing/0001730463-24-000007

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