Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI

Rhea-AI Summary

Revelation Biosciences (NASDAQ:REVB) said it reached agreement with the FDA on an approval pathway for Gemini to treat Acute Kidney Injury (AKI). The agency agreed that a single adaptive Phase 2/3 randomized, double-blind, placebo-controlled study of approximately 300 patients using a clinically relevant composite primary endpoint (death and/or need for dialysis) plus positive data would be sufficient for an NDA. Revelation plans to build trial infrastructure, engage a CRO, assemble scientific advisors, manufacture clinical supply, and work to initiate the study during 2026.

Positive

• FDA agreed on a clear approval pathway for Gemini
• Single Phase 2/3 adaptive study can support an NDA
• Primary endpoint is objective: death and/or need for dialysis
• Planned randomized, double-blind, placebo-controlled design
• Company targeting study initiation and infrastructure build in 2026

Negative

• Approval contingent on a single study producing positive data
• No clinical efficacy or safety data disclosed yet
• Critical trial infrastructure (CRO, drug supply) not yet complete

News Market Reaction

-10.08% 42.4x vol

56 alerts

-10.08% News Effect

+10.5% Peak Tracked

-34.3% Trough Tracked

-$789K Valuation Impact

$7M Market Cap

42.4x Rel. Volume

On the day this news was published, REVB declined 10.08%, reflecting a significant negative market reaction. Argus tracked a peak move of +10.5% during that session. Argus tracked a trough of -34.3% from its starting point during tracking. Our momentum scanner triggered 56 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $789K from the company's valuation, bringing the market cap to $7M at that time. Trading volume was exceptionally heavy at 42.4x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Planned study size: 300 patients US hospital admissions: 34 million AKI incidence: 20% +3 more

6 metrics

Planned study size 300 patients Single Phase 2/3 adaptive clinical study for Gemini in AKI

US hospital admissions 34 million Annual US hospital admissions cited by American Hospital Association

AKI incidence 20% Proportion of hospitalized patients found to have AKI

AKI patients 6.8 million Estimated number of US hospital patients with AKI each year

Medicare AKI spend $10 billion CDC estimate of 2015 Medicare annual expenditure for AKI

Per-patient AKI cost $42,077 CDC estimate of AKI-related costs per Medicare patient in 2015

Market Reality Check

Price: $1.90 Vol: Volume 56,644 is below th...

low vol

$1.90 Last Close

Volume Volume 56,644 is below the 20-day average of 96,133 (relative volume 0.59). low

Technical Shares at $0.9342 are trading below the $3.13 200-day moving average and 95.54% below the 52-week high.

Peers on Argus

REVB was down 1.56% pre-news while peers showed mixed moves: QLGN +7.72%, GLTO +...

REVB was down 1.56% pre-news while peers showed mixed moves: QLGN +7.72%, GLTO +15.54%, ENTO -5.68%, SLXN -2.61%, ELAB +0.93%, suggesting stock-specific factors.

Historical Context

5 past events · Latest: Jan 14 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 14	Conference presentation	Positive	-0.6%	PRIME study Gemini data presentation at critical care nephrology conference.
Jan 12	Equity inducement grant	Neutral	+0.0%	Inducement RSU grant to new employee under Nasdaq Rule 5635(c)(4).
Jan 07	GMP manufacturing start	Positive	-1.1%	Initiation of GMP manufacturing for Gemini and placebo for later trials.
Dec 01	Special meeting & progress	Positive	+0.1%	Quorum for special meeting and confirmation of FDA regulatory progress.
Nov 20	Regulatory milestone	Positive	-0.5%	End-of-Phase 1 package accepted and Phase 1b safety/biomarker success.

Pattern Detected

Recent positive development and regulatory headlines around Gemini often coincided with flat or slightly negative next-day price moves.

Recent Company History

Over the last few months, Revelation has steadily advanced Gemini toward later-stage development. On Nov 20, 2025, the FDA accepted its end-of-Phase 1 package after a Phase 1b study met safety and tolerability endpoints. By Jan 7, 2026, GMP manufacturing for Gemini and placebo was initiated to support randomized, double-blind, placebo-controlled trials. Subsequent news included a special meeting quorum and conference presentations on PRIME data. Today’s agreement on a single Phase 2/3 adaptive study aligns with this progression toward a clearly defined approval path.

Regulatory & Risk Context

Active S-3 Shelf · $28,743,000

Shelf Active

Active S-3 Shelf Registration 2025-09-29

$28,743,000 registered capacity

An effective Form S-3/A shelf for Class I warrant exercises allows the company to receive up to $28,743,000 in cash proceeds if all registered warrants at $2.20 per share are exercised, providing potential future funding without a concurrent primary sale in this prospectus.

Market Pulse Summary

The stock dropped -10.1% in the session following this news. A negative reaction despite clarity on ...

Analysis

The stock dropped -10.1% in the session following this news. A negative reaction despite clarity on the FDA pathway would fit a pattern where prior positive Gemini updates were followed by modest declines, even as development advanced. Investors may focus on execution risk around the single Phase 2/3 trial of roughly 300 patients and the company’s reliance on external financing, including warrant structures allowing up to $28,743,000 in potential proceeds, as they assess dilution and timing of future capital needs.

Key Terms

acute kidney injury, aki, adaptive design, randomized, +4 more

8 terms

acute kidney injury medical

"approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI)."

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

aki medical

"approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI)."

Acute kidney injury (AKI) is a sudden decline in kidney function that prevents the body from clearing waste and balancing fluids and salts, like a plumbing system that abruptly clogs and overflows. For investors, AKI matters because it can drive demand for treatments, affect the safety and outcomes of clinical trials, trigger regulatory scrutiny or product liability risks, and influence revenue and cost forecasts for healthcare companies.

adaptive design medical

"Single Phase 2/3 Adaptive Study Design -- Clinically Relevant, Objective Composite Endpoint"

Adaptive design is a way to run clinical trials that lets researchers change aspects of the study—such as dose, sample size, or which patient groups are studied—based on data gathered while the trial is ongoing, without starting over. For investors, it matters because this flexibility can shorten development time, reduce costs, and increase the chance of finding a successful outcome, similar to steering a ship toward calmer waters as conditions change.

randomized medical

"The planned adaptive Phase 2/3 design will be a randomized, double-blind, placebo-controlled study"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"design will be a randomized, double-blind, placebo-controlled study, and will be comprised of two parts."

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"design will be a randomized, double-blind, placebo-controlled study, and will be comprised of two parts."

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

dialysis medical

"composite endpoint comprising death and/or need for dialysis, and 2) positive data"

Dialysis is a medical treatment that cleans the blood and removes extra fluid when the kidneys can no longer do that job, using a machine or a filtered solution much like an external water filter for the body. It matters to investors because dialysis creates steady demand for specialized clinics, machines, supplies and drugs, driving predictable revenue streams, capital and regulatory risks, and long-term patient volumes that affect healthcare company valuations.

new drug application regulatory

"would be sufficient for submission of a new drug application (NDA)."

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

AI-generated analysis. Not financial advice.

- Single Phase 2/3 Adaptive Study Design -

- Clinically Relevant, Objective Composite Endpoint -

SAN DIEGO, CA / ACCESS Newswire / January 21, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, announced that the Company has reached agreement with the FDA on an approval pathway for Gemini as a treatment for Acute Kidney Injury (AKI). The two key agreements were 1) a clinically relevant and objective composite endpoint comprising death and/or need for dialysis, and 2) positive data from a single well-controlled Phase 2/3 adaptive design clinical study, comprising approximately 300 patients, would be sufficient for submission of a new drug application (NDA). This agreement significantly advances Gemini toward becoming a paradigm altering treatment available for patients suffering from AKI, a significant unmet medical need.

"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 Revelation. "As we enter this exciting phase of development, the Revelation team will remain focused on completing the key activities required for the successful execution of this pivotal study."

Revelation reached agreement with FDA on a single adaptive clinical study design with a clearly defined and achievable patient-centered endpoint. The advantage of an adaptive design Phase 2/3 study is the ability to transition rapidly from Phase 2 to Phase 3, with an opportunity to sufficiently power the Phase 3 portion of the study. The planned adaptive Phase 2/3 design will be a randomized, double-blind, placebo-controlled study, and will be comprised of two parts. Part 1 will evaluate different dosing regimens vs placebo and part 2 will be conducted as a Phase 3 study using the safest dosing regimen identified in part 1. Data from both part 1 and part 2 can be used in the primary and secondary endpoint analyses. The primary endpoint will be a composite of measures including death and/or the need for dialysis.

The American Hospital Association states that approximately 34 million people are admitted to US hospitals each year. It was found that 20% or approximately 6.8 million patients admitted to hospitals had AKI by the University of Florida. The CDC says Medicare in 2015 alone had an annual expenditure of over $10 billion and growing for AKI, with spending for AKI related costs of approximately $42,077 per patient. The only treatment for severe AKI is dialysis which increases the potential for worse outcomes including death, therefore Gemini could be the first available therapy for this significant unmet medical need. This data is an indication of how large the AKI market is and the potential for Gemini.

Over the course of 2026, Revelation will continue to build the infrastructure required to successfully conduct this clinical study, including engagement of a top-tier clinical research organization specializing in hospital-based renal studies, establishing an expert panel of scientific advisors, and completing the manufacture of clinical drug supply. Revelation is working expeditiously toward initiating the Phase 2/3 study.

About Gemini
Gemini is the Company's proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD^®), a toll-like receptor 4 (TLR4) agonist. TLR4 stimulation with Gemini rebalances the innate immune response and has been demonstrated to have the potential to treat acute and chronic diseases associated with dysregulated inflammation. Gemini is currently being evaluated as a potential treatment for acute kidney injury (GEM-AKI). Gemini is also being developed as a treatment for chronic kidney disease (GEM-CKD), as a treatment to reduce hyperinflammation and infection associated with severe burn (GEM-PBI), and as a treatment to prevent post-surgical infection (GEM-PSI). The potential of Gemini to correct dysregulated inflammation has been demonstrated in multiple preclinical models of AKI, CKD, and infection, as well as in two phase 1 clinical studies. See additional detail here.

About AKI
Acute Kidney Injury or AKI, also known as acute renal failure, is defined as a rapid loss of kidney function. AKI causes a build-up of waste products in blood and makes it more difficult for kidneys to maintain the correct balance of fluid in the body. AKI can also significantly impact other organs such as the brain, heart, and lungs. Severe AKI requiring dialysis significantly increases the likelihood of worse outcomes including longer time in an ICU, potential to develop chronic kidney disease, and death.

AKI is a major cause of morbidity and mortality, affecting more than 10% of all hospitalized patients and more than 50% of patients admitted to intensive care units. Renal replacement therapy (dialysis) is still the only therapeutic option in the treatment of the consequences of severe AKI and is required in approximately 20% of all critically ill patients. AKI is associated with high mortality rates, and even among those who survive, up to 40% later develop chronic kidney disease or progress to end-stage renal disease. As such, new therapies to treat AKI are urgently needed.

About Revelation Biosciences, Inc.
Revelation Biosciences, Inc. is a clinical stage life sciences company focused on rebalancing inflammation using its proprietary formulation, Gemini. Revelation has multiple ongoing programs to evaluate Gemini as a treatment for acute kidney injury, a treatment of chronic kidney disease, prevention of post-surgical infection, and a treatment to reduce hyperinflammation and infection associated with severe burn.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management's expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation's product candidates; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for its product candidates; potential indications for which product candidates may be developed; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation's balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

Company Contact
Mike Porter
Investor Relations
Porter LaVay & Rose Inc.
Email: mike@plrinvest.com

Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com

SOURCE: Revelation Biosciences, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Revelation Biosciences (REVB) agree with the FDA for Gemini on January 21, 2026?

The FDA agreed that positive data from a single adaptive Phase 2/3 study (~300 patients) using a composite endpoint of death and/or dialysis could support an NDA for Gemini.

What is the primary endpoint for the Gemini Phase 2/3 study (REVB)?

The primary endpoint is a clinically relevant composite comprising death and/or need for dialysis.

How large is the planned Gemini adaptive study that Revelation (REVB) discussed?

The agreed Phase 2/3 adaptive study is planned to comprise approximately 300 patients.

What study design will Revelation use for Gemini (REVB)?

A randomized, double-blind, placebo-controlled adaptive Phase 2/3 study with two parts: dose-finding (part 1) and Phase 3 (part 2).

When does Revelation expect to initiate the Gemini Phase 2/3 study (REVB)?

Revelation is working to build infrastructure and aims to initiate the study during 2026.

What market figures did Revelation cite about AKI relevant to Gemini (REVB)?

They cited ~34 million annual US hospital admissions, ~6.8 million AKI cases (~20%), and prior Medicare AKI spending noted at over $10 billion in 2015 with ~$42,077 per patient.