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

REVELATION BIOSCIENCES, INC.

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.

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