Revelation Biosciences Announces The FDA Has Accepted Its End-Of-Phase 1 Meeting Package For Gemini, Its Acute Kidney Injury Treatment Candidate

Author: Benzinga Newsdesk | November 20, 2025 09:05am

Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, today announced successful submission and acceptance of the end-of-phase 1 meeting package to FDA and that the company is on track to hold the meeting later this year. The primary purpose of this meeting is to establish agency feedback and input into the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI).

"The Revelation team has worked tirelessly on our end-of-phase 1 meeting submission, and we look forward to our FDA meeting scheduled for later this year," said James Rolke, Chief Executive Officer of Revelation. "Our near-term focus will be conducting the necessary activities for initiating and running a later stage clinical study during 2026 to evaluate the ability of Gemini to effectively treat AKI. In addition, we plan to publish additional positive results from the PRIME study that completed this year and to expand potential uses of Gemini for other conditions through preclinical and clinical testing."

Revelation recently announced positive safety and activity data from its Phase 1b PRIME clinical study in stage 3 and 4 chronic kidney disease patients. The primary endpoint to evaluate the safety and tolerability of escalating doses of Gemini was met. In addition, the potential of Gemini to treat acute and chronic inflammatory conditions was demonstrated by significantly reducing inflammatory activity and restoring normal cellular response to stimuli at the cellular level, as measured in peripheral blood mononuclear cells (PBMCs) isolated from patients at predose, 2, 24, and 168 hours post-dose.

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