{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-110370","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2025-08-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.581735+00:00","generated_at":"2026-05-17T11:09:39.079996+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Iterum launches ORLYNVAH, first oral penem antibiotic in U.S., for uUTI","bullets":["FDA approved ORLYNVAH in Oct 2024; commercial launch announced Aug 20, 2025.","First oral penem antibiotic in U.S.; first new branded uUTI product in >25 years.","57% of initial uUTIs resistant to at least one antibiotic class per 2024 study.","Copay savings program allows eligible patients to get ORLYNVAH for as low as $25.","CEO cites urgent need for new oral therapies amid rising antibiotic resistance."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-110370","json":"https://secwatch.observer/filing/0000950170-25-110370.json","markdown":"https://secwatch.observer/filing/0000950170-25-110370.md","text":"https://secwatch.observer/filing/0000950170-25-110370.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017025110370/0000950170-25-110370-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017025110370/itrm-20250820.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:09:39.079996+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"}