{"schema_version":"secwatch.filing_event.v1","accession":"0001645113-26-000010","form_type":"8-K","ticker":"NVCR","cik":"0001645113","company_name":"NovoCure Ltd","filed_at":"2026-02-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.732207+00:00","generated_at":"2026-05-16T03:20:05.936759+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA Approves Novocure's Optune Pax for Locally Advanced Pancreatic Cancer","bullets":["FDA approval based on Phase 3 PANOVA-3 trial in 571 patients with locally advanced pancreatic cancer.","Median overall survival improved to 16.2 months vs 14.2 months (HR 0.82, p=0.039).","Time to pain progression extended by 6.1 months (15.2 vs 9.1 months).","First new treatment approved for locally advanced pancreatic cancer in nearly 30 years.","Optune Pax well-tolerated; most adverse events were mild-to-moderate skin reactions under arrays."],"urls":{"canonical":"https://secwatch.observer/filing/0001645113-26-000010","json":"https://secwatch.observer/filing/0001645113-26-000010.json","markdown":"https://secwatch.observer/filing/0001645113-26-000010.md","text":"https://secwatch.observer/filing/0001645113-26-000010.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645113/000164511326000010/0001645113-26-000010-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645113/000164511326000010/nvcr-20260211.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-16T03:20:05.936759+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"}