{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-006804","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2024-01-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.148878+00:00","generated_at":"2026-06-06T16:29:07.851543+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":"Iovance discloses FDA clinical hold on NSCLC TIL trial; BLA for lifileucel in melanoma under review","bullets":["FDA placed clinical hold on IOV-LUN-202 trial (NSCLC) on Dec 22, 2023; new enrollment paused.","BLA for lifileucel in advanced melanoma under FDA review with final label discussions ongoing.","Presentation reports $428M cash as of 9/30/23 and 90%+ manufacturing success rate.","Proleukin acquisition closed May 18, 2023 for £167.7M upfront; completed.","Melanoma data: ORR 31.4% (pooled cohorts 2&4) with median DOR not reached at 36.5 months."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-006804","json":"https://secwatch.observer/filing/0001104659-24-006804.json","markdown":"https://secwatch.observer/filing/0001104659-24-006804.md","text":"https://secwatch.observer/filing/0001104659-24-006804.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924006804/0001104659-24-006804-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924006804/tm244175d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T16:29:07.851543+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"}