{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-21-326173","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2021-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:04:13.578046+00:00","generated_at":"2026-06-28T10:00:35.437433+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"UroGen to start new Phase 3 study for UGN-102; stops ATLAS enrollment","bullets":["New single-arm Phase 3 pivotal study for UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer expected to start early 2022, enrolling ~220 patients at 90 sites.","ATLAS trial enrollment halted; patients already enrolled may remain until completion.","Company believes new study design increases regulatory success probability; NDA submission for UGN-102 remains on track for 2024.","UGN-301: non-human primate toxicity studies underway; multi-arm Phase 1 study planned early 2022 with combination approaches."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-21-326173","json":"https://secwatch.observer/filing/0001193125-21-326173.json","markdown":"https://secwatch.observer/filing/0001193125-21-326173.md","text":"https://secwatch.observer/filing/0001193125-21-326173.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000119312521326173/0001193125-21-326173-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000119312521326173/d244400d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T10:00:35.437433+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"}