{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-075997","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2024-06-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.361107+00:00","generated_at":"2026-06-01T00:30:32.046269+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iovance submits MAA to EMA for lifileucel in advanced melanoma; first of multiple global filings","bullets":["MAA seeks approval for lifileucel after prior PD-1 and BRAF/MEK therapy; would be first approved TIL therapy in EU.","Submission supported by Phase 2 C-144-01 trial data; validation expected Q3 2024; CHMP opinion in 2025.","Additional marketing submissions planned in Canada and UK in H2 2024, and Australia in 2025.","Targets >20,000 patients annually in U.S., EU, UK, Canada, and Australia with advanced melanoma.","EU expansion follows U.S. accelerated approval of lifileucel (Amtagvi) in February 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-075997","json":"https://secwatch.observer/filing/0001104659-24-075997.json","markdown":"https://secwatch.observer/filing/0001104659-24-075997.md","text":"https://secwatch.observer/filing/0001104659-24-075997.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924075997/0001104659-24-075997-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924075997/tm2418485d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T00:30:32.046269+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"}