Revelation Biosciences Submits FDA Meeting Package for Gemini AKI Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
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Source: Newsfilter
- FDA Meeting Preparation: Revelation Biosciences has successfully submitted the end-of-phase 1 meeting package for Gemini as a treatment for acute kidney injury, with a meeting scheduled with the FDA later this year. This milestone represents a significant step in the clinical development and regulatory approval pathway, potentially accelerating Gemini's market entry.
- Clinical Research Progress: The company plans to initiate a later-stage clinical study in 2026 to evaluate Gemini's effectiveness in treating acute kidney injury. This study will provide additional data to support Gemini's clinical applications, further advancing its use in kidney disease treatment.
- PRIME Study Results: Revelation achieved positive safety and activity data from its Phase 1b PRIME study, demonstrating that Gemini significantly reduces inflammation levels in chronic kidney disease patients. These results lay the groundwork for Gemini's potential applications in acute and chronic inflammatory conditions, enhancing its market competitiveness.
- Market Demand Context: Acute kidney injury affects over 10% of hospitalized patients, with limited existing treatment options, making the development of Gemini timely to meet this urgent market need. As demand for new therapies rises, Revelation is well-positioned to capture a significant share in the kidney disease treatment sector.
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Analyst Views on REVB
About REVB
Revelation Biosciences, Inc. is a clinical-stage life sciences company, which is focused on rebalancing inflammation to optimize health using its proprietary formulation Gemini. The Company's product candidates are based on the Gemini formulation of phosphorylated hexaacyl disaccharide (PHAD). The Company has multiple ongoing programs to evaluate Gemini, including GEM-AKI as a prevention of acute kidney injury (AKI), GEM-CKD as a treatment for chronic kidney disease (CKD), and GEM-PSI as a prevention of post-surgical infection (PSI). The Gemini-AKI program is being developed as a potential therapy for the prevention of AKI due to external stress or insult, such as surgical procedure and chemotherapy toxicity. GEM-PSI is being developed as a potential therapy for the prevention or treatment of healthcare-associated bacterial infections, including post-surgical infection, post-burn infection, urinary tract infection, sepsis, and antibiotic-resistant infection.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Revelation Biosciences Executes Third Reverse Stock Split in a Year
- Frequent Reverse Splits: Revelation Biosciences announced a 1-for-4 reverse stock split effective January 28, 2026, marking its third reverse split in a year aimed at boosting share price to meet Nasdaq's minimum bid requirements.
- Financing Plan: Last week, the company agreed to exercise outstanding warrants to purchase up to 13.1 million shares at a discounted price of $0.86 per share, expecting gross proceeds of $11 million, which enhances its liquidity position.
- FDA Approval Pathway: Revelation reached an agreement with the U.S. FDA on an approval pathway for Gemini as a treatment for acute kidney injury, planning a well-controlled adaptive Phase 2/3 clinical study involving about 300 patients to support a new drug application.
- Market Sentiment Analysis: Despite a more than 10% drop in stock price on the announcement day, retail sentiment on Stocktwits remained in the 'extremely bullish' territory, indicating confidence in the company's future prospects.
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Revelation Biosciences (REVB) Secures FDA Agreement for Gemini Drug's Clinical Trial Pathway
- Regulatory Clarity: REVB has reached an agreement with the FDA that a single Phase 2/3 adaptive study will support a future NDA for treating acute kidney injury, marking a significant advancement in addressing a major unmet medical need.
- Clinical Trial Design: The planned randomized, double-blind, placebo-controlled trial will enroll approximately 300 patients and utilize an adaptive design for rapid dose selection, directly impacting patient survival rates by evaluating the safest and most effective treatment options in Phase 3.
- Significant Market Potential: With an estimated 6.8 million U.S. hospital admissions involving AKI annually and Medicare spending exceeding $10 billion on related care, Gemini's first-in-class therapy could fill a critical market gap and significantly improve patient outcomes.
- Future Plans: REVB aims to finalize the infrastructure for the pivotal study in 2026, including engaging a top-tier CRO, establishing a scientific advisory panel, and completing the manufacturing of clinical-grade Gemini drug supply to ensure a smooth study initiation.
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