{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-198589","form_type":"8-K","ticker":"SPRO","cik":"0001701108","company_name":"Spero Therapeutics, Inc.","filed_at":"2023-07-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.903488+00:00","generated_at":"2026-06-12T22:09:55.845430+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA agrees to SPA for Spero's Phase 3 tebipenem HBr trial; $30M milestone due from GSK","bullets":["FDA granted Special Protocol Assessment (SPA) for pivotal Phase 3 PIVOT-PO trial of oral tebipenem HBr vs IV imipenem in cUTI/acute pyelonephritis.","Positive results from PIVOT-PO plus prior studies could support FDA approval for a limited use indication.","Spero to receive $30M development milestone from GSK upon invoicing; additional milestones up to $495M plus tiered royalties.","PIVOT-PO first patient first visit expected in Q4 2023; trial uses 10% non-inferiority margin per FDA guidance.","SPR720 Phase 2 enrollment continues; top-line data now expected in H2 2024 (slower than prior guidance)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-198589","json":"https://secwatch.observer/filing/0001193125-23-198589.json","markdown":"https://secwatch.observer/filing/0001193125-23-198589.md","text":"https://secwatch.observer/filing/0001193125-23-198589.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1701108/000119312523198589/0001193125-23-198589-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1701108/000119312523198589/d518650d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-12T22:09:55.845430+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"}