secwatch.observer — SEC 8-K summary
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Issuer:     Autolus Therapeutics plc (AUTL)
CIK:        0001730463
Form:       8-K
Filed at:   2024-06-05T23:59:59+00:00
Accession:  0001730463-24-000074
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Autolus publishes UK Annual Report; provides obe-cel BLA status, PDUFA date Nov 16, 2024
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- BLA for obe-cel accepted by FDA; PDUFA target action date set for 16 November 2024.
- Phase 2 FELIX study data: 78% CR/CRi rate in evaluable r/r adult B-ALL patients; median follow-up 16.6 months.
- First two patients enrolled in CARLYSLE Phase 1 trial of obe-cel for SLE; initial data expected by end of 2024.
- In Phase 1 ALLCAR19 trial, 41% of patients in ongoing remission at 3-year median follow-up without transplant.
- AUTO1/22 dual-targeting CAR T showed 83% MRD-negative complete remission in paediatric r/r B-ALL.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1730463/000173046324000074/0001730463-24-000074-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1730463/000173046324000074/autl-20240605.htm
  HTML page:      https://secwatch.observer/filing/0001730463-24-000074

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