{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-018332","form_type":"8-K","ticker":"REVB","cik":"0001810560","company_name":"REVELATION BIOSCIENCES, INC.","filed_at":"2026-01-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.262059+00:00","generated_at":"2026-05-16T08:52:54.672289+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Revelation Biosciences reaches FDA agreement on approval pathway for Gemini AKI treatment","bullets":["FDA agreed single Phase 2/3 adaptive study (~300 patients) can support NDA for Gemini in AKI.","Primary composite endpoint: death and/or need for dialysis; clinically relevant and objective.","Study design: randomized, double-blind, placebo-controlled; Part 1 dose finding, Part 2 Phase 3.","Company to engage CRO, advisors, and manufacture drug supply in 2026 before study start."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-018332","json":"https://secwatch.observer/filing/0001193125-26-018332.json","markdown":"https://secwatch.observer/filing/0001193125-26-018332.md","text":"https://secwatch.observer/filing/0001193125-26-018332.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1810560/000119312526018332/0001193125-26-018332-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1810560/000119312526018332/revb-20260121.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T08:52:54.672289+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"}