{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-002290","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2024-01-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.148668+00:00","generated_at":"2026-06-07T02:09:11.964349+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Iovance updates pipeline: BLA under review, NSCLC trial on hold","bullets":["BLA for lifileucel in advanced melanoma under FDA review; pre-license inspection of iCTC facility completed in 2023.","Clinical hold placed on IOV-LUN-202 NSCLC trial on Dec 22, 2023; enrollment paused, prior patients continue monitoring.","Phase 2 C-144-01 pooled melanoma data: ORR 31.4%, median DOR not reached, 41.7% of responses lasting ≥24 months.","Phase 3 TILVANCE-301 frontline melanoma trial first patient randomized in 2Q23; dual primary endpoints ORR and PFS.","Cash $428M as of Sep 30, 2023; Proleukin acquisition for £167.7M upfront closed May 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-002290","json":"https://secwatch.observer/filing/0001104659-24-002290.json","markdown":"https://secwatch.observer/filing/0001104659-24-002290.md","text":"https://secwatch.observer/filing/0001104659-24-002290.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924002290/0001104659-24-002290-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924002290/tm242451d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T02:09:11.964349+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"}