Revelation Biosciences Congratulates Former Chairman on FDA Appointment

Revelation Biosciences congratulates former chairman George Tidmarsh on his appointment as head of the FDA Center for Drug Evaluation and Research. Tidmarsh previously served as chairman and shareholder of Revelation, and was a founder of La Jolla Pharmaceutical Company. He has a background in biotech innovation and has led several companies, taking multiple medications from ideation to FDA approval. Revelation also announced the completion of dosing for its PRIME Phase 1b clinical study of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease.

Revelation Biosciences, Inc. (NASDAQ: REVB), a clinical-stage life sciences company focused on rebalancing inflammation to optimize health, has announced the appointment of its former chairman and shareholder, Dr. George Tidmarsh, M.D., Ph.D., as the new Director of the FDA's Center for Drug Evaluation and Research (CDER). Dr. Tidmarsh's appointment was officially announced by the U.S. Food and Drug Administration on July 24, 2025 [1].

Dr. Tidmarsh, who served as chairman of the board of Revelation Biosciences and was a founder of La Jolla Pharmaceutical Company, brings over three decades of experience in biotechnology, clinical medicine, and regulatory science to his new role. He is known for his ability to foster innovation and has led the successful clinical development of seven FDA-approved drugs. Dr. Tidmarsh's appointment to lead CDER underscores the FDA's commitment to strengthening its drug review programs and fostering innovation [1].

In addition to his appointment, Revelation Biosciences announced the completion of dosing for its PRIME Phase 1b clinical study of escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The study is expected to yield several data sets, including safety standards, changes in hematologic parameters, in vitro evaluation, and multiple biomarkers of activity, during Q3, 2025 [3].

Gemini is a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®) that reduces the damage associated with inflammation by reprogramming the innate immune system to respond to stress in an attenuated manner. It is being developed for multiple indications, including as a pretreatment to prevent or reduce the severity and duration of acute kidney injury (GEMINI-AKI program), and as pretreatment to prevent or reduce the severity and duration of post-surgical infection (GEMINI-PSI program), or infection post severe burn (GEMINI-PBI). Gemini may also be a treatment to stop or slow the progression of chronic kidney disease (GEMINI-CKD program) [3].

Revelation Biosciences congratulates Dr. Tidmarsh on his new role and looks forward to his continued support in advancing the company's innovative treatments. The appointment of Dr. Tidmarsh is expected to enhance the FDA's ability to ensure safe, effective, and high-quality drugs are available to the American people [1].

References:
[1] https://www.fda.gov/news-events/press-announcements/stanford-faculty-member-george-tidmarsh-md-phd-named-director-center-drug-evaluation-and-research
[2] https://www.mmm-online.com/news/the-escalator-novartis-avalere-health-ipsen-and-more/
[3] https://biotuesdays.com/2025/07/17/revelation-completes-patient-dosing-in-study-of-gemini-in-ckc/