{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-079364","form_type":"8-K","ticker":"IOVA","cik":"0001425205","company_name":"IOVANCE BIOTHERAPEUTICS, INC.","filed_at":"2023-07-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.887168+00:00","generated_at":"2026-06-13T10:31:59.772146+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iovance gets FDA positive feedback for TIL therapy in NSCLC; 26.1% ORR in 23 patients","bullets":["FDA Type B meeting supports IOV-LUN-202 trial design for accelerated approval of LN-145 in post-anti-PD-1 advanced NSCLC.","Preliminary data cut shows 26.1% ORR (6/23 patients) with one complete response and five partial responses; disease control rate 82.6%.","Plans to enroll ~120 patients in registrational trial; enrollment expected complete H2 2024.","Lifileucel BLA for advanced melanoma remains on Priority Review; PDUFA date Nov 25, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-079364","json":"https://secwatch.observer/filing/0001104659-23-079364.json","markdown":"https://secwatch.observer/filing/0001104659-23-079364.md","text":"https://secwatch.observer/filing/0001104659-23-079364.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1425205/000110465923079364/0001104659-23-079364-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1425205/000110465923079364/tm2320915d3_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T10:31:59.772146+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"}