{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-054714","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2023-10-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.970873+00:00","generated_at":"2026-06-09T14:17:06.215203+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iterum completes enrollment in Phase 3 uUTI trial; topline data expected early Q1 2024","bullets":["Completed enrollment in REASSURE trial of oral sulopenem vs Augmentin in uncomplicated UTIs ahead of schedule.","Topline data expected early Q1 2024; NDA resubmission planned for Q2 2024 subject to data analysis.","FDA review expected within 6 months of resubmission, with action anticipated in H2 2024, if deficiencies addressed.","Sulopenem is a novel oral penem; company notes it could be first new uUTI antibiotic approved in over 25 years."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-054714","json":"https://secwatch.observer/filing/0000950170-23-054714.json","markdown":"https://secwatch.observer/filing/0000950170-23-054714.md","text":"https://secwatch.observer/filing/0000950170-23-054714.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017023054714/0000950170-23-054714-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017023054714/itrm-20231024.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T14:17:06.215203+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"}