{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-075885","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2024-06-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.469286+00:00","generated_at":"2026-06-01T02:52:26.604165+00:00","sec_items":["5.07","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iterum Therapeutics gets FDA Advisory Committee meeting on Sept 9, 2024 for oral sulopenem NDA for uUTI","bullets":["FDA Advisory Committee to discuss NDA for oral sulopenem (first oral penem in U.S.) for uUTI in adult women; proposed date September 9, 2024.","Discussion topics: antimicrobial stewardship issues and appropriate target patient population.","PDUFA action date set at October 25, 2024 for Class II resubmission."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-075885","json":"https://secwatch.observer/filing/0000950170-24-075885.json","markdown":"https://secwatch.observer/filing/0000950170-24-075885.md","text":"https://secwatch.observer/filing/0000950170-24-075885.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024075885/0000950170-24-075885-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024075885/itrm-20240619.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T02:52:26.604165+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"}