Revelation Biosciences Inc. (NASDAQ:REVB) surged 25.22% in after-hours trading to $1.07 on Thursday after the company announced it reached agreement with the Food and Drug Administration on an approval pathway for its proprietary drug candidate Gemini as a treatment for acute kidney injury (AKI).
The stock closed Thursday at $0.85, up 1.71%, according to Benzinga Pro data.
Single Phase 2/3 Study Sufficient For Application
The FDA agreed on two key points: a composite endpoint of death and/or the need for dialysis and that positive results from a single Phase 2/3 adaptive study of about 300 patients would be enough for a new drug application submission.
“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,” said James Rolke, chief executive officer of the California- based clinical-stage company.
The randomized, double-blind, placebo-controlled trial will assess dosing regimens in Part 1 before moving into a Phase 3 study in Part 2.
Revelation on Wednesday stated that the University of Florida found that 20% of hospital admissions, or approximately 6.8 million patients annually, involved acute kidney injury (AKI).
Trading Metrics, Technical Analysis
The biopharmaceutical company has a market capitalization of $5.06 million, with its stock trading in a 52-week range of $0.71 to $19.34.
The stock has a Relative Strength Index (RSI) of 42.01.
Revelation Biosciences stock has seen a dramatic decline over the past year, down 94.48%.
The stock is positioned at approximately 0.75% of its 52-week range, very close to the low.
The stock’s sharp decline and its position near the bottom of the 52-week range suggest significant pressure, signaling elevated risk and the need for clear signs of recovery before sentiment can improve.
Benzinga’s Edge Stock Rankings indicate REVB stock has a negative price trend across all time frames.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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