{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-129751","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2023-12-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.031116+00:00","generated_at":"2026-06-07T06:51:30.382173+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA places clinical hold on Iovance's LN-145 NSCLC trial after fatal adverse event","bullets":["FDA placed clinical hold on IOV-LUN-202 on Dec 22, 2023, after a Grade 5 fatal SAE potentially linked to preconditioning.","Enrollment paused; previously treated patients monitored; those with tumor resection continue with risk mitigations.","No impact on other Iovance trials or lifileucel BLA; PDUFA date remains Feb 24, 2024.","Updated Nov 2023 data: 71% of confirmed responders had duration of response >6 months.","Iovance will work with FDA to resume enrollment safely."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-129751","json":"https://secwatch.observer/filing/0001104659-23-129751.json","markdown":"https://secwatch.observer/filing/0001104659-23-129751.md","text":"https://secwatch.observer/filing/0001104659-23-129751.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465923129751/0001104659-23-129751-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465923129751/tm2333764d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T06:51:30.382173+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"}