{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-200993","form_type":"8-K","ticker":"URGN","cik":"0001668243","company_name":"UroGen Pharma Ltd.","filed_at":"2024-08-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.036641+00:00","generated_at":"2026-05-31T09:01:40.370602+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"UroGen Pharma submits NDA to FDA for UGN-102 for low-grade intermediate-risk NMIBC","bullets":["Completed NDA submission for UGN-102 to the U.S. FDA.","UGN-102 is intended for low-grade intermediate-risk non-muscle invasive bladder cancer treatment.","Regulatory submission marks a key milestone toward potential approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-200993","json":"https://secwatch.observer/filing/0001193125-24-200993.json","markdown":"https://secwatch.observer/filing/0001193125-24-200993.md","text":"https://secwatch.observer/filing/0001193125-24-200993.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1668243/000119312524200993/0001193125-24-200993-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1668243/000119312524200993/d834673d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T09:01:40.370602+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"}