{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-066932","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2024-05-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.469081+00:00","generated_at":"2026-06-01T07:11:07.061260+00:00","sec_items":["5.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Iterum receives FDA acceptance of oral sulopenem NDA resubmission; PDUFA date Oct 25, 2024","bullets":["FDA accepted resubmission of NDA for oral sulopenem for uUTIs in adult women; PDUFA action date set for October 25, 2024.","Nasdaq granted 180-day extension until September 30, 2024 to regain compliance with minimum stockholders' equity requirement.","CMO Sailaja Puttagunta steps down effective May 31, 2024; will serve as consultant at $400/hour during regulatory review.","Resubmission includes REASSURE trial data showing oral sulopenem non-inferior to Augmentin and statistically superior for overall success."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-066932","json":"https://secwatch.observer/filing/0000950170-24-066932.json","markdown":"https://secwatch.observer/filing/0000950170-24-066932.md","text":"https://secwatch.observer/filing/0000950170-24-066932.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024066932/0000950170-24-066932-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024066932/itrm-20240529.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T07:11:07.061260+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":[{"claim_id":"7298263c55","claim":"Sailaja Puttagunta resigned as Chief Medical Officer at Iterum Therapeutics plc.","evidence_excerpt":"Dr. Puttagunta, whose previously announced resignation as CMO is effective as of May 31, 2024","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1659323/000095017024066932/0000950170-24-066932-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"resigned"},{"label":"Role","value":"Chief Medical Officer"}],"fact_type":"executive_change"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}