{"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","discovered_at":"2026-05-14T18:03:25.290639+00:00","generated_at":"2026-06-06T16:37:14.452565+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Autolus Therapeutics announces FDA acceptance of BLA for obe-cel; PDUFA date Nov 16, 2024","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001730463-24-000007","json":"https://secwatch.observer/filing/0001730463-24-000007.json","markdown":"https://secwatch.observer/filing/0001730463-24-000007.md","text":"https://secwatch.observer/filing/0001730463-24-000007.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T16:37:14.452565+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}