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.
The company expects to spend much of 2026 building the necessary infrastructure for the trial, including the engagement of specialized clinical research organizations and the completion of GMP manufacturing for clinical drug supply.
With the path to approval now clearly defined, Revelation is moving expeditiously to initiate the adaptive study, targeting a massive unmet market where the current standard of care is limited to supportive dialysis.