secwatch.observer — SEC 8-K summary
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Issuer:     REVELATION BIOSCIENCES, INC. (REVB)
CIK:        0001810560
Form:       8-K
Filed at:   2026-01-22T23:59:59+00:00
Accession:  0001193125-26-018332
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1810560/000119312526018332/0001193125-26-018332-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1810560/000119312526018332/revb-20260121.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-018332

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer