---
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"
generated_at: "2026-05-16T08:52:54.672289+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Revelation Biosciences reaches FDA agreement on approval pathway for Gemini AKI treatment

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-018332
- JSON: https://secwatch.observer/filing/0001193125-26-018332.json
- Plain text: https://secwatch.observer/filing/0001193125-26-018332.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.