Revelation Biosciences announced that the U.S. Food and Drug Administration has accepted the company’s end‑of‑Phase 1 meeting package for its Gemini platform, a toll‑like receptor 4 agonist designed to treat acute kidney injury (AKI). The acceptance signals that the FDA has reviewed the data and documentation and is ready to discuss the company’s clinical development plan, a critical step that can shape the design of subsequent trials and potentially accelerate the approval pathway.
Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) that rebalances the innate immune response to reduce inflammation. The platform has shown promise in early‑stage studies, including a Phase 1b PRIME trial that demonstrated a reduction in inflammatory activity in patients with chronic kidney disease. The FDA meeting will allow Revelation to obtain feedback on dosing, trial design, and regulatory strategy for the upcoming Phase 2 study in AKI patients.
The company said the meeting is scheduled for later in 2025, after the FDA’s acceptance. A successful discussion will provide the company with guidance on the design of the Phase 2 trial, including patient selection, endpoints, and potential regulatory pathways. The meeting also offers an opportunity to clarify the company’s regulatory strategy and address any concerns that could affect the drug’s approval trajectory.
Revelation remains a pre‑revenue, clinical‑stage company. As of September 30, 2025, it held $12.7 million in cash, a strong current ratio of 6.92, and no debt. The company has reported significant net losses, with a trailing‑12‑month earnings per share of –$44.07, reflecting the heavy investment required to advance its pipeline. The firm has been actively raising capital through offerings and warrant exercises to support its clinical program and future growth.
CEO James Rolke said, “The team has worked tirelessly on our end‑of‑phase 1 meeting submission, and we look forward to the FDA meeting scheduled for later this year. Our near‑term focus will be conducting the necessary activities for initiating and running a later‑stage clinical study in 2026 to evaluate Gemini’s ability to treat AKI. We also plan to publish additional positive results from the PRIME study and to expand Gemini’s potential uses for other conditions through preclinical and clinical testing.” The statement underscores the company’s commitment to advancing Gemini while acknowledging the need for continued funding.
Acute kidney injury affects more than 10 % of hospitalized patients and over 50 % of intensive‑care patients, yet current treatment options are limited to dialysis for severe cases. A successful regulatory milestone for Gemini could position Revelation as a pioneer in a high‑unmet‑need therapeutic area, potentially transforming the standard of care for AKI and related inflammatory kidney conditions.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.