REVELATION BIOSCIENCES, INC. 8-K

What Happened Revelation Biosciences, Inc. (REVB) filed a Form 8-K (filed Jan 22, 2026) reporting that on January 21, 2026 the company announced it reached agreement with the U.S. Food and Drug Administration on a development and approval pathway for its Gemini program in acute kidney injury (AKI). The company said the FDA agreed to a single adaptive-design Phase 2/3 registration study and an approvable composite endpoint. Revelation also posted an updated corporate presentation on its website and attached the press release and presentation to the 8-K.

Key Details

• Date of announcement: January 21, 2026; Form 8-K filed January 22, 2026.
• Agreed pathway: single adaptive Phase 2/3 registration study for Gemini in AKI.
• Regulatory outcome: FDA agreed on an approvable composite endpoint for the program.
• Company materials: press release and corporate presentation were made public and attached as Exhibits 99.1 and 99.2 to the 8-K.
• Filing signed by CFO Chester S. Zygmont, III.

Why It Matters This filing signals that Revelation has alignment with the FDA on how to run pivotal clinical testing for Gemini in AKI, which clarifies the regulatory path toward potential approval. For investors, FDA agreement on study design and an approvable endpoint can reduce regulatory uncertainty and support planning for trial timing and potential value milestones. The filing itself does not include clinical data or financial impacts; it documents the regulatory meeting outcome and provides company materials for investors to review.