{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-008530","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2024-01-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.008029+00:00","generated_at":"2026-06-06T15:03:36.837004+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Iterum's oral sulopenem meets Phase 3 uUTI endpoint, shows superiority over Augmentin","bullets":["Primary endpoint met: overall success 61.7% (sulopenem) vs 55.0% (Augmentin); 95% CI lower bound >0 showing statistical superiority.","No serious adverse events on sulopenem; discontinuations <1% in both arms; safety consistent with prior trials.","NDA resubmission planned for Q2 2024; FDA action expected in Q4 2024 if deficiencies addressed.","Company initiating strategic process to sell, license, or dispose of sulopenem rights to maximize value."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-008530","json":"https://secwatch.observer/filing/0000950170-24-008530.json","markdown":"https://secwatch.observer/filing/0000950170-24-008530.md","text":"https://secwatch.observer/filing/0000950170-24-008530.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024008530/0000950170-24-008530-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024008530/itrm-20240130.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T15:03:36.837004+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"}