Revelation Biosciences secures FDA path for AKI trial

Revelation Biosciences filed an 8-K to share that it has reached agreement with the FDA on an approval pathway for its Gemini program in acute kidney injury (AKI).

Accepted by SEC EDGAR 01/21/2026 - 07:01 PM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Revelation Biosciences filed an 8-K to share that it has reached agreement with the FDA on an approval pathway for its Gemini program in acute kidney injury (AKI). The company reports that the FDA meeting supported a single adaptive design Phase 2/3 registration study and an approvable composite endpoint, which together outline how the pivotal trial could be structured to support a potential marketing application.

The company also released a press release and an updated corporate presentation, both dated January 21, 2026, and made them available on its website. These materials, furnished as exhibits, provide additional detail on the regulatory path and the AKI program but are not treated as filed financial statements.

Positive

• Regulatory clarity gained for AKI program: The company reports FDA agreement on an approval pathway, including a single adaptive Phase 2/3 registration study and an approvable composite endpoint for its Gemini acute kidney injury program, marking a significant development milestone.

Negative

• None.

Insights

Biotech regulatory and clinical development analyst

FDA alignment on a Phase 2/3 design for AKI is a key regulatory milestone.

Revelation Biosciences states it has reached agreement with the FDA on an approval pathway for its Gemini program in acute kidney injury, centered on a single adaptive design Phase 2/3 registration study and an approvable composite endpoint. In drug development, such agreement defines how a pivotal trial can support a future marketing application, reducing uncertainty around study structure and endpoints.

The focus on a single adaptive Phase 2/3 study can streamline development by allowing mid-course adaptations within a registration-intent trial, though success will still depend on clinical outcomes and execution quality. The mention of an approvable composite endpoint suggests FDA has provided feedback on which combined clinical measures could support approval.

The company has furnished a press release and corporate presentation with more detail, but they are explicitly described as furnished rather than filed, which is typical for investor communications. Subsequent disclosures about trial initiation, enrollment progress, and data from this planned Phase 2/3 study will be critical to understand how this regulatory pathway translates into clinical and commercial prospects.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Revelation Biosciences (REVB) disclose in this 8-K filing?

Revelation Biosciences disclosed that it reached agreement with the FDA on an approval pathway for its Gemini program in acute kidney injury, based on a single adaptive design Phase 2/3 registration study with an approvable composite endpoint, and it furnished a related press release and corporate presentation.

What is the significance of the FDA agreement mentioned by REVB?

The agreement with the FDA provides regulatory clarity for Revelation Biosciences’ Gemini acute kidney injury program by outlining a single adaptive Phase 2/3 registration study and an approvable composite endpoint, which defines how a pivotal trial could support a potential marketing application.

What additional materials did Revelation Biosciences make available with this 8-K?

Revelation Biosciences furnished a press release titled “Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI” and an updated corporate presentation, both dated January 21, 2026, and made them available on its website as Exhibits 99.1 and 99.2.

Are the REVB press release and presentation considered filed financial information?

No. The company states that the information in Item 8.01 and in Exhibits 99.1 and 99.2 is being furnished and is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, nor automatically incorporated by reference into other filings.

Does this 8-K include new financial results for Revelation Biosciences (REVB)?

The 8-K focuses on regulatory and corporate information, specifically the FDA agreement on the Gemini approval pathway and the availability of a corporate presentation and press release; it does not present earnings or detailed financial results.

What securities of Revelation Biosciences are listed on Nasdaq?

The filing lists Revelation Biosciences’ common stock, par value $0.001 per share, trading under the symbol REVB, and redeemable warrants trading under the symbol REVBW, each warrant exercisable for a 1/50,400th share of common stock at an exercise price of $579,600 per share.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 21, 2026

REVELATION BIOSCIENCES, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-39603	84-3898466
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
4660 La Jolla Village Drive Suite 100
San Diego, California				92122
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 800-3717

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.001 per share		REVB		The Nasdaq Stock Market LLC
Redeemable warrants, each exercisable for a 1/50,400th share of common stock at an exercise price of $579,600 per share		REVBW		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Information.

On January 21, 2026, Revelation Biosciences, Inc. (the “Company”) issued a press release titled “Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI” announcing results of its meeting with FDA for a single Adaptive design Phase 2/3 registration study and approvable composite endpoint. Additionally, the Company made an updated corporate presentation available to the public, the corporate presentation can be found on the Company’s website. A copy of the press release and presentation are attached to this Current Report on Form 8-K as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated herein by reference.

The information in this Item 8.01 and in Exhibit 99.1 and 99.2 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release, dated January 21, 2026
99.2		Corporate Presentation, dated January 21, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

		REVELATION BIOSCIENCES, INC.
Date: January 21, 2026	By:	/s/ Chester S. Zygmont, III
		Chester S. Zygmont, III Chief Financial Officer (principal financial and accounting officer)