{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-277506","form_type":"8-K","ticker":"SPRO","cik":"0001701108","company_name":"Spero Therapeutics, Inc.","filed_at":"2026-06-22T20:05:06+00:00","discovered_at":"2026-06-22T20:06:00.293382+00:00","generated_at":"2026-06-22T20:11:14.325933+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":"FDA approves Spero Therapeutics' Utebzi, first oral carbapenem for cUTIs","bullets":["Utebzi (tebipenem pivoxil) approved June 17, 2026 for complicated UTIs in adults with limited oral alternatives.","PIVOT-PO trial showed 58.5% overall success vs 60.2% for IV imipenem-cilastatin (adjusted diff -1.3%).","Most common AEs were diarrhea and headache; all mild/moderate and non-serious.","GSK holds exclusive global license (excl. select Asia); BARDA supported development.","Product anticipated to be available in US by end of 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-277506","json":"https://secwatch.observer/filing/0001193125-26-277506.json","markdown":"https://secwatch.observer/filing/0001193125-26-277506.md","text":"https://secwatch.observer/filing/0001193125-26-277506.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1701108/000119312526277506/0001193125-26-277506-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1701108/000119312526277506/d51395d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-22T20:11:14.325933+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"}