---
schema_version: "secwatch.filing_event.v1"
accession: "0001730463-23-000115"
form_type: "8-K"
ticker: "AUTL"
cik: "0001730463"
company_name: "Autolus Therapeutics plc"
filed_at: "2023-11-27T23:59:59+00:00"
generated_at: "2026-06-07T21:31:34.559113+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Autolus submits BLA to FDA for cell therapy obe-cel in r/r adult B-ALL

## Summary
- 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.

## SEC filing metadata
- accession: 0001730463-23-000115
- form_type: 8-K
- ticker: AUTL
- cik: 0001730463
- company_name: Autolus Therapeutics plc
- filed_at: 2023-11-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1730463/000173046323000115/0001730463-23-000115-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1730463/000173046323000115/autl-20231127.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001730463-23-000115
- JSON: https://secwatch.observer/filing/0001730463-23-000115.json
- Plain text: https://secwatch.observer/filing/0001730463-23-000115.txt

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