{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-080304","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2025-08-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.959325+00:00","generated_at":"2026-05-17T11:23:54.089385+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Iovance's Amtagvi receives Health Canada approval for advanced melanoma","bullets":["Health Canada issued NOC/c for Amtagvi (lifileucel) for unresectable/metastatic melanoma after anti-PD-1 and targeted therapy.","First marketing authorization outside the U.S.; first T cell therapy approved for a solid tumor cancer in Canada.","Approval based on Phase 2 C-144-01 trial ORR and DOR by IRC; results published in 2022 and 2025 journals.","Iovance expects to authorize first Canadian treatment center within next few months; advancing ex-U.S. strategy.","Amtagvi is also being investigated in frontline advanced melanoma (Phase 3 TILVANCE-301) and other solid tumors."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-080304","json":"https://secwatch.observer/filing/0001104659-25-080304.json","markdown":"https://secwatch.observer/filing/0001104659-25-080304.md","text":"https://secwatch.observer/filing/0001104659-25-080304.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465925080304/0001104659-25-080304-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465925080304/tm2523802d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:23:54.089385+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"}