---
schema_version: "secwatch.filing_event.v1"
accession: "0001730463-24-000007"
form_type: "8-K"
ticker: "AUTL"
cik: "0001730463"
company_name: "Autolus Therapeutics plc"
filed_at: "2024-01-26T23:59:59+00:00"
generated_at: "2026-06-06T16:37:14.452565+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Autolus Therapeutics announces FDA acceptance of BLA for obe-cel; PDUFA date Nov 16, 2024

## Summary
- 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.

## SEC filing metadata
- accession: 0001730463-24-000007
- form_type: 8-K
- ticker: AUTL
- cik: 0001730463
- company_name: Autolus Therapeutics plc
- filed_at: 2024-01-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1730463/000173046324000007/0001730463-24-000007-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1730463/000173046324000007/autl-20240122.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001730463-24-000007
- JSON: https://secwatch.observer/filing/0001730463-24-000007.json
- Plain text: https://secwatch.observer/filing/0001730463-24-000007.txt

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