Revelation Biosciences Inc. (NASDAQ: REVB) experienced a significant stock surge of 25.22% in after-hours trading, reaching $1.07 on Thursday. This jump followed the company’s announcement regarding an agreement with the Food and Drug Administration (FDA) concerning the approval pathway for its proprietary drug candidate, Gemini, aimed at treating acute kidney injury (AKI). The stock had closed at $0.85 earlier that day, reflecting a modest increase of 1.71%, according to data from Benzinga Pro.
FDA Agreement on Approval Pathway
The FDA confirmed two essential aspects of the approval process for Gemini. First, it accepted a composite endpoint that includes both mortality and the necessity for dialysis. Second, the FDA indicated that positive results from a single Phase 2/3 adaptive study involving approximately 300 patients would suffice for a new drug application submission.
James Rolke, the chief executive officer of Revelation Biosciences, expressed gratitude for the FDA’s collaborative feedback, stating, “We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI.” This trial will begin with a randomized, double-blind, placebo-controlled study assessing different dosing regimens before transitioning into a Phase 3 study.
Recent research from the University of Florida highlighted the prevalence of AKI, revealing that around 20% of hospital admissions, or approximately 6.8 million patients annually, involve this condition. This statistic underscores the potential market for effective treatments like Gemini.
Trading Metrics and Market Context
Revelation Biosciences currently holds a market capitalization of approximately $5.06 million. The stock has traded within a 52-week range of $0.71 to $19.34. Despite the recent surge, the stock has experienced a dramatic decline over the past year, down 94.48%. Presently, it stands at about 0.75% of its 52-week range, positioning it very close to its low point.
The stock’s steep decline and its current position suggest significant market pressure, indicating elevated risk and the necessity for clear signs of recovery before investor sentiment improves. According to Benzinga’s Edge Stock Rankings, REVB stock has exhibited a negative price trend across all time frames, further illustrating the challenges facing the company.
As the biopharmaceutical landscape continues to evolve, the developments surrounding Revelation Biosciences and its Gemini treatment will be closely watched by investors and healthcare professionals alike.
