Revelation Biosciences (NASDAQ:REVB) announced it has reached a milestone agreement with the FDA on an "expedient" approval pathway for Gemini, its lead candidate for the treatment of Acute Kidney Injury (AKI).
The San Diego-based company secured two critical regulatory concessions that significantly de-risk the program's timeline.
First, the FDA agreed that a single, well-controlled Phase 2/3 adaptive design study of approximately 300 patients would be sufficient for a New Drug Application (NDA) submission.
Second, the agency approved a composite primary endpoint focused on objective, patient-centered outcomes: death and/or the need for dialysis.
This agreement provides Revelation with a clear "pivotal" roadmap, allowing the company to transition seamlessly from dose-finding in Phase 2 to a powered efficacy analysis in Phase 3 within the same study.
CEO James Rolke hailed the collaboration as a "paradigm-altering" step for a condition that currently has no FDA-approved pharmaceutical therapies.
AKI affects approximately 20% of all hospitalized patients in the U.S.—roughly 6.8 million people annually—and carries a staggering Medicare expenditure of over $10 billion.
By utilizing Gemini, a toll-like receptor 4 (TLR4) agonist designed to "rebalance" the innate immune system, Revelation aims to prevent the progressive scarring and organ failure that often follows surgical trauma or severe infection.