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Revelation Biosciences, Inc. (stock symbol: REVB) is a clinical-stage life sciences company dedicated to advancing immunologic therapeutics and diagnostics designed to improve global health. At the core of its innovative endeavors is Gemini, a proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD), an established TLR4 agonist. This formulation is designed to stimulate the body's innate immune response to prevent and treat various diseases.
The company is actively developing a pipeline of high-value product candidates based on this unique Gemini formulation. These programs include:
- Gemini-SSI: Focused on preventing surgical site infections (SSI).
- Gemini-AKI: Aimed at preventing acute kidney injury (AKI).
- Gemini-CKD: Targeted at treating chronic kidney disease (CKD).
Revelation Biosciences, Inc. is committed to leveraging the science of trained immunity through the Gemini-based products to address significant unmet medical needs and improve patient outcomes. The company continues to make strides in their clinical trials and research, aiming for groundbreaking advancements in healthcare.
With a strong focus on innovation and a dedication to enhancing patient health, Revelation Biosciences, Inc. stands as a significant player in the biotech industry, promising solutions to some of the most challenging health conditions.
Revelation Biosciences announced that its Phase 1 clinical study of Gemini met its primary safety endpoint and showed statistically significant biomarker activity. The study, conducted with 40 healthy volunteers aged 18-55 in Australia, found that Gemini was safe and well-tolerated at pharmacologically active doses. Significant dose-dependent changes in key biomarkers, such as interleukin-1RA, neutrophil gelatinase lipocalin, C-reactive protein, and IL-6, were observed, indicating the drug's immunostimulatory effects. The Phase 1 results support further development across multiple indications, including acute kidney injury prevention and postoperative infection prevention. The maximum tolerated dose identified will guide the upcoming Phase 1b study in chronic kidney disease patients planned for late 2024.
Revelation Biosciences (NASDAQ: REVB) has completed enrollment and dosing of its first-in-human Phase 1 clinical study (RVL-HV02) for Gemini, conducted in Australia.
The study evaluated escalating doses of intravenously administered Gemini in 40 healthy individuals aged 18-55. The forthcoming top-line data will assess safety and tolerability, along with biomarkers to demonstrate immune response stimulation.
Positive data could support Gemini's future development for multiple indications, including reducing acute kidney injury and post-surgical infections.
Preclinical studies have shown promising results in reducing AKI severity and bacterial infections.
Revelation's CEO, James Rolke, highlighted the milestone's significance for addressing critical unmet needs.
Revelation Biosciences, Inc. (NASDAQ: REVB) announced its financial results for the three months ended March 31, 2024. The company reported $14.6 million in cash and cash equivalents, up from $12.0 million in December 2023. They stated that the current cash is enough to fund operations through 2024. However, they reported a net loss of $2.7 million for the quarter, with significant expenses related to GEM-AKI and GEM-SSI clinical studies impacting their financials.
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