{"schema_version":"secwatch.filing_event.v1","accession":"0001730463-24-000129","form_type":"8-K","ticker":"AUTL","cik":"0001730463","company_name":"Autolus Therapeutics plc","filed_at":"2024-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.390371+00:00","generated_at":"2026-05-30T02:03:30.221906+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Autolus' AUCATZYL (obe-cel) for adult r/r B-ALL; no REMS required","bullets":["Approval based on FELIX trial: 63% overall complete remission (CR/CRi) in efficacy-evaluable patients (n=65); median DOR 14.1 months.","Only 3% Grade ≥3 CRS and 7% Grade ≥3 ICANS; no REMS program required by FDA.","Boxed warning for CRS, neurologic toxicities, secondary hematological malignancies; T-cell malignancies risk noted.","Commercial manufacturing at Nucleus in Stevenage, UK; Cardinal Health as U.S. distribution partner.","EU and UK MAAs under review; company to host conference call Nov 11."],"urls":{"canonical":"https://secwatch.observer/filing/0001730463-24-000129","json":"https://secwatch.observer/filing/0001730463-24-000129.json","markdown":"https://secwatch.observer/filing/0001730463-24-000129.md","text":"https://secwatch.observer/filing/0001730463-24-000129.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1730463/000173046324000129/0001730463-24-000129-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1730463/000173046324000129/autl-20241108.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T02:03:30.221906+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"}