{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-026878","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2024-03-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.008450+00:00","generated_at":"2026-06-05T02:42:57.345460+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Iterum expects NDA resubmission for oral sulopenem in Q2 2024; cash runway into 2025","bullets":["NDA resubmission for oral sulopenem to FDA expected in first half of Q2 2024, earlier than originally planned.","FDA action expected six months after resubmission (first half of Q4 2024), assuming deficiencies addressed.","Cash and equivalents as of Dec 31, 2023 plus ATM proceeds through Feb 29, 2024 expected to fund ops into 2025, including through PDUFA date.","Company plans to engage financial advisor to assist with strategic alternatives (sale, license, or disposal of rights to sulopenem)."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-026878","json":"https://secwatch.observer/filing/0000950170-24-026878.json","markdown":"https://secwatch.observer/filing/0000950170-24-026878.md","text":"https://secwatch.observer/filing/0000950170-24-026878.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024026878/0000950170-24-026878-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024026878/itrm-20240306.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T02:42:57.345460+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"}