{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-117270","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2024-10-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.134225+00:00","generated_at":"2026-05-30T10:04:05.354345+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Iterum receives FDA approval for ORLYNVAH for uUTIs; first product approval","bullets":["FDA approved ORLYNVAH (oral sulopenem) for uUTIs in adult women with limited/no alternative oral antibiotics.","Approval based on Phase 3 trials SURE 1 (superior to ciprofloxacin) and REASSURE (non-inferior to Augmentin, statistical superiority).","ORLYNVAH is first oral penem approved in U.S. and Iterum's first FDA-approved product.","Company renews efforts for strategic transaction (sale/partnership/license) involving ORLYNVAH to maximize value.","Approximately 40M uUTI prescriptions annually in U.S.; ~1% resistant to all common oral antibiotics, addressing unmet need."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-117270","json":"https://secwatch.observer/filing/0000950170-24-117270.json","markdown":"https://secwatch.observer/filing/0000950170-24-117270.md","text":"https://secwatch.observer/filing/0000950170-24-117270.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024117270/0000950170-24-117270-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024117270/itrm-20241025.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T10:04:05.354345+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"}