Revelation Biosciences Inc (REVB) is experiencing a significant decline of 16.86% in pre-market trading, hitting a 52-week low.
The company has reached an agreement with the FDA regarding its Gemini drug, which is set to undergo a Phase 2/3 adaptive study aimed at treating acute kidney injury (AKI). This agreement marks a crucial step in the drug's development, as positive results from this study will support a future new drug application (NDA). The FDA's endorsement reflects confidence in the Gemini program, which has the potential to address a significant market need, given the high number of annual hospital admissions for AKI.
The implications of this FDA agreement are substantial, as it not only paves the way for further clinical trials but also positions Revelation Biosciences to potentially capture a significant share of the market for AKI treatments, which could lead to improved patient outcomes and financial performance in the future.
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.
