Revelation Biosciences Inc. (NASDAQ: REVB) saw its stock price increase by an impressive 25.22% in after-hours trading on Thursday, reaching $1.07, following the announcement of an agreement with the Food and Drug Administration (FDA) regarding the approval pathway for its drug candidate, Gemini. The stock had closed earlier that day at $0.85, marking a gain of 1.71% according to data from Benzinga Pro.
FDA Agreement and Study Details
The FDA reached a consensus with Revelation Biosciences on two significant aspects: the use of a composite endpoint that includes both death and the necessity for dialysis, and the acceptance of results from a single Phase 2/3 adaptive study involving approximately 300 patients as sufficient for a new drug application.
James Rolke, the chief executive officer of the California-based clinical-stage company, expressed gratitude for the FDA’s collaborative feedback. “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,” he stated.
This upcoming study will involve a randomized, double-blind, placebo-controlled trial. The first part of the study will evaluate different dosing regimens before transitioning into the Phase 3 portion.
Background on Acute Kidney Injury and Market Position
According to research from the University of Florida, acute kidney injury (AKI) accounts for approximately 20% of hospital admissions, affecting around 6.8 million patients annually in the United States. This statistic underscores the potential impact of a successful treatment for this condition.
Revelation Biosciences, which currently has a market capitalization of $5.06 million, has experienced a tumultuous year, with its stock price plummeting 94.48% over the past twelve months. The stock has traded within a 52-week range of $0.71 to $19.34, and its current position is approximately 0.75% of its 52-week range, suggesting it is nearing its historical low.
Technical analysis indicates a negative price trend across all time frames for REVB stock, reflecting significant pressure and heightened risk. Investors may be looking for clear signs of recovery before sentiment can shift positively.
As the company moves forward with its clinical trials and navigates the regulatory landscape, the outcome of these efforts will be critical in determining its future trajectory in the biopharmaceutical market.
