Revelation Biosciences Inc. (NASDAQ:REVB) experienced a significant surge in its stock price, climbing by 25.22% in after-hours trading to reach $1.07 on Thursday. This uptick followed the company’s announcement that it had reached an agreement with the Food and Drug Administration (FDA) regarding an approval pathway for its proprietary drug candidate, Gemini, aimed at treating acute kidney injury (AKI). The stock closed at $0.85 during regular trading hours, reflecting an increase of 1.71% according to data from Benzinga Pro.
FDA Agreement and Study Details
The FDA’s agreement hinges on two critical points. First, the agency approved a composite endpoint of death and/or 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 collaborative feedback from the FDA, 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.”
The clinical trial will be randomized, double-blind, and placebo-controlled. It will assess various dosing regimens in Part 1 before transitioning into a Phase 3 study during Part 2.
Market Performance and Challenges
Revelation Biosciences, headquartered in California, currently holds a market capitalization of $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, plummeting by 94.48%.
With the current trading position approximating 0.75% of its 52-week range, the stock is near its lowest point. This decline, combined with its position at the bottom of the range, indicates significant market pressure, suggesting that investors may require clear signs of recovery before sentiment improves.
According to Benzinga’s Edge Stock Rankings, REVB stock reflects a negative price trend across all time frames, highlighting the ongoing challenges the company faces in regaining investor confidence.
As Revelation Biosciences moves forward with its clinical trials and navigates the complexities of the regulatory landscape, the market will closely monitor their progress and the potential impact of Gemini on the treatment of acute kidney injury.
