{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-049928","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2024-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.468475+00:00","generated_at":"2026-06-03T05:37:33.202010+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iterum resubmits NDA for oral sulopenem to FDA for uUTIs; potential approval early Q4 2024","bullets":["Resubmitted NDA on April 29, 2024, for oral sulopenem (sulopenem etzadroxil/probenecid) for uncomplicated UTIs in adult women.","REASSURE trial showed oral sulopenem non-inferior and statistically superior to Augmentin in uUTI patients with susceptible pathogens.","SURE 1 trial demonstrated statistical superiority of oral sulopenem vs ciprofloxacin in patients with quinolone non-susceptible pathogens.","FDA review expected to complete six months from receipt; potential approval early Q4 2024, addressing July 2021 CRL deficiencies.","If approved, would be first oral penem in the U.S. and second new oral uUTI treatment in over 25 years."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-049928","json":"https://secwatch.observer/filing/0000950170-24-049928.json","markdown":"https://secwatch.observer/filing/0000950170-24-049928.md","text":"https://secwatch.observer/filing/0000950170-24-049928.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024049928/0000950170-24-049928-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024049928/itrm-20240429.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T05:37:33.202010+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"}