{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-238439","form_type":"8-K","ticker":"SPRO","cik":"0001701108","company_name":"Spero Therapeutics, Inc.","filed_at":"2022-09-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:56.701909+00:00","generated_at":"2026-06-23T15:31:07.557397+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Spero Therapeutics: FDA agrees single additional Phase 3 trial could support approval of tebipenem HBr for cUTI","bullets":["FDA indicated positive results from one additional Phase 3 trial, plus confirmatory nonclinical evidence, could support approval.","Spero plans to advance tebipenem HBr development and potential commercialization through external partnership.","Type A meeting follows June 2022 CRL; FDA aligned on key components for pivotal trial design, with possible SPA.","If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the U.S."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-238439","json":"https://secwatch.observer/filing/0001193125-22-238439.json","markdown":"https://secwatch.observer/filing/0001193125-22-238439.md","text":"https://secwatch.observer/filing/0001193125-22-238439.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1701108/000119312522238439/0001193125-22-238439-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1701108/000119312522238439/d331031d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T15:31:07.557397+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"}