{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-025082","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2024-02-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.149081+00:00","generated_at":"2026-06-05T22:57:17.970314+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Iovance receives FDA accelerated approval for AMTAGVI (lifileucel) in advanced melanoma","bullets":["AMTAGVI is first FDA-approved T cell therapy for a solid tumor cancer, indicated for advanced melanoma after anti-PD-1 and BRAF/MEK therapy.","Pivotal cohort (n=73) showed 31.5% objective response rate; median duration of response not reached at 18.6 months follow-up.","Preliminary cash, equivalents, investments, and restricted cash of $346.3M as of Dec 31, 2023, including $114.9M cash and equivalents.","Iovance Cell Therapy Center in Philadelphia has capacity for several thousand patients annually; 30+ authorized treatment centers prepared.","Phase 3 confirmatory trial TILVANCE-301 ongoing; boxed warning includes treatment-related mortality and severe cytopenia."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-025082","json":"https://secwatch.observer/filing/0001104659-24-025082.json","markdown":"https://secwatch.observer/filing/0001104659-24-025082.md","text":"https://secwatch.observer/filing/0001104659-24-025082.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924025082/0001104659-24-025082-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465924025082/tm246580d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T22:57:17.970314+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"}