Revelation Biosciences Inc. (NASDAQ:REVB) experienced a notable increase in its stock price, surging by 25.22% to reach $1.07 in after-hours trading on Thursday. This jump follows the company’s announcement of a significant agreement with the Food and Drug Administration (FDA) regarding the approval pathway for its proprietary drug candidate, Gemini, intended for the treatment of acute kidney injury (AKI). Prior to this announcement, the stock closed at $0.85, reflecting a modest gain of 1.71% during regular trading hours.
FDA Agreement and Study Details
The FDA’s agreement centers on two critical aspects: a composite endpoint that involves either death or the necessity for dialysis, and the acceptance of positive outcomes from a single Phase 2/3 adaptive study involving approximately 300 patients as sufficient for a new drug application submission. James Rolke, the chief executive officer of the California-based clinical-stage company, expressed gratitude for the “collaborative feedback” from the FDA, emphasizing that it provides a “clear and expedient path forward” for the approval of Gemini as a treatment option for AKI.
The upcoming trial will feature a randomized, double-blind, placebo-controlled framework. Initially, it will evaluate different dosing regimens in the first part before advancing to a Phase 3 study in the subsequent phase. According to research from the University of Florida, approximately 20% of all hospital admissions—equating to around 6.8 million patients annually—are linked to acute kidney injury, highlighting the potential impact of Gemini.
Market Performance and Trading Metrics
Revelation Biosciences has a current market capitalization of $5.06 million. Over the past year, the stock has faced a dramatic decline, down 94.48%, with trading fluctuating within a 52-week range of $0.71 to $19.34. Currently, the stock is positioned at approximately 0.75% of its 52-week range, placing it near its low point.
The stock’s substantial decline indicates significant market pressure, reflecting elevated risk levels and the necessity for definitive signs of recovery before investor sentiment can shift positively. According to Benzinga’s Edge Stock Rankings, REVB stock is currently exhibiting a negative price trend across all timeframes.
As Revelation Biosciences moves forward with its clinical trial and seeks FDA approval, the landscape for its stock remains uncertain, hinging on the results of its upcoming studies and the broader market conditions.
