{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-182828","form_type":"8-K","ticker":"SPRO","cik":"0001701108","company_name":"Spero Therapeutics, Inc.","filed_at":"2022-06-27T23:59:59+00:00","discovered_at":"2026-05-14T18:04:01.893043+00:00","generated_at":"2026-06-24T22:57:49.070748+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA rejects Spero's tebipenem HBr NDA for cUTI; additional clinical study required","bullets":["Received Complete Response Letter on June 27, 2022 for tebipenem HBr oral tablets cUTI NDA.","FDA determined Phase 3 ADAPT-PO study insufficient; additional clinical study needed.","Company plans to request a Type A meeting with FDA to discuss path forward.","CEO expressed disappointment but commitment to pursue regulatory approval and potential partnerships."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-182828","json":"https://secwatch.observer/filing/0001193125-22-182828.json","markdown":"https://secwatch.observer/filing/0001193125-22-182828.md","text":"https://secwatch.observer/filing/0001193125-22-182828.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1701108/000119312522182828/0001193125-22-182828-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1701108/000119312522182828/d373789d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T22:57:49.070748+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"}