{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-160413","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2024-06-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.503747+00:00","generated_at":"2026-06-01T04:38:05.055819+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"UroGen reports positive DOR data from Phase 3 ENVISION trial for UGN-102 in bladder cancer","bullets":["12-month DOR KM estimate for CR patients: 82.3% (95% CI: 75.9%-87.1%); predicted median DOR of 40 months.","ENVISION met primary endpoint with 79.6% CR rate at 3 months; safety profile mild-to-moderate.","Rolling NDA submission to FDA for UGN-102 to complete Q3 2024; potential acceptance Q4 2024, approval Q1/Q2 2025.","If approved, UGN-102 would be first FDA-approved medicine for LG-IR-NMIBC; addressable market over $5B (82K patients, $16-19K/dose).","UGN-102 offers a non-surgical alternative to TURBT; ~68% of patients have 2+ recurrences and repeated TURBT carries adverse event risks."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-160413","json":"https://secwatch.observer/filing/0001193125-24-160413.json","markdown":"https://secwatch.observer/filing/0001193125-24-160413.md","text":"https://secwatch.observer/filing/0001193125-24-160413.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000119312524160413/0001193125-24-160413-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000119312524160413/d852084d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T04:38:05.055819+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"}