{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-128680","form_type":"8-K","ticker":"SPRO","cik":"0001701108","company_name":"Spero Therapeutics, Inc.","filed_at":"2025-05-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.387571+00:00","generated_at":"2026-05-20T08:19:19.515083+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Spero/GSK Phase 3 PIVOT-PO trial for tebipenem HBr meets primary endpoint, stops early for efficacy","bullets":["Tebipenem HBr met non-inferiority vs IV imipenem-cilastatin in 1,690 cUTI patients; IDMC recommended early stop.","No new safety concerns; diarrhea and headache most common adverse events.","GSK plans FDA filing in second half 2025; could be first oral carbapenem for cUTIs in US.","cUTIs affect ~2.9M US cases/year with >$6B in healthcare costs; IV-only standard currently.","Supported by BARDA funding and QIDP/Fast Track designations from FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-128680","json":"https://secwatch.observer/filing/0001193125-25-128680.json","markdown":"https://secwatch.observer/filing/0001193125-25-128680.md","text":"https://secwatch.observer/filing/0001193125-25-128680.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1701108/000119312525128680/0001193125-25-128680-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1701108/000119312525128680/d903768d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T08:19:19.515083+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"}