{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-140339","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2025-06-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.272556+00:00","generated_at":"2026-05-19T08:31:12.792845+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"FDA approves UroGen Pharma's ZUSDURI (mitomycin) for recurrent LG-IR-NMIBC","bullets":["FDA approved ZUSDURI (mitomycin) for adults with recurrent low-grade intermediate-risk NMIBC on June 12, 2025.","Phase 3 ENVISION trial: 78% achieved complete response at 3 months; 79% of those maintained at 12 months.","Expected commercial availability in the U.S. on or around July 1, 2025.","Common adverse reactions include increased creatinine, dysuria, hematuria; serious reactions in 12% of patients.","Post-marketing commitment: ongoing ENVISION trial to further characterize clinical benefit; annual duration of response updates."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-140339","json":"https://secwatch.observer/filing/0001193125-25-140339.json","markdown":"https://secwatch.observer/filing/0001193125-25-140339.md","text":"https://secwatch.observer/filing/0001193125-25-140339.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000119312525140339/0001193125-25-140339-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000119312525140339/d98388d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T08:31:12.792845+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"}