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Revelation Biosciences Announces Initiation of GMP Manufacturing of GEMINI and Placebo to Support Later Stage Clinical Development
SAN DIEGO, CA / ACCESS Newswire / January 7, 2026 /Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, today announced the start of GMP manufacturing ...
About this update from Revelation Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, CA / ACCESS Newswire / January 7, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, today announced the start of GMP manufacturing of GEMINI and placebo. This manufacturing run will provide the Company with clinical drug supply for later stage clinical studies.","length":409,"tagName":"p"},{"type":"text","content":""We are delighted to be working with a leading global contract manufacturing organization," said James Rolke, Chief Executive Officer of Revelation. "The manufacture of additional drug supply and placebo will fulfill a critical step in advancing Revelation's pipeline and accelerating timelines for upcoming clinical programs."","length":351,"tagName":"p"},{"type":"text","content":"The manufacture of drug and Placebo enables the company to conduct randomized double blinded, placebo-controlled clinical studies, and is an integral part of the broader strategy to move Gemini toward approval.","length":210,"tagName":"p"},{"type":"text","content":"Revelation met with FDA in December 2025 and is currently awaiting the official meeting minutes. The primary purpose of this meeting was to establish agency feedback and input into the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI).","length":294,"tagName":"p"},{"type":"text","content":"About Gemini","length":12,"tagName":"p"},{"type":"text","content":"Gemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEMINI-AKI program). Gemini is also being developed as a treatment for chronic kidney disease (GEMINI-CKD program), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI) and as a treatment to prevent post-surgical infection (GEMINI-PSI program). The potential of Gemini has been demonstrated in multiple preclinical models of AKI, CKD and infection, as w...