FRACTYL HEALTH, INC. 8-K

What Happened Fractyl Health, Inc. (GUTS) announced on May 11, 2026 (via Form 8-K, Item 7.01) that it received Clinical Trial Application (CTA) authorization in the Netherlands to initiate the Phase 1/2 first-in-human study of RJVA-001, the company’s first clinical candidate from its Rejuva® Smart GLP-1™ gene therapy platform. The company furnished a press release about the authorization as Exhibit 99.1 to the 8-K.

Key Details

• CTA authorization granted in the Netherlands to start a Phase 1/2 first-in-human study.
• Investigational product: RJVA-001, the first clinical candidate from the Rejuva® Smart GLP-1™ gene therapy platform.
• Announcement made and press release furnished on May 11, 2026 (Form 8-K, Item 7.01; Exhibit 99.1).
• Disclosure made under Regulation FD (filed as Item 7.01 on the Current Report).

Why It Matters This is a regulatory and development milestone: authorization to begin human testing moves RJVA-001 from preclinical development into clinical trials, marking the company’s advance toward evaluating safety and early efficacy in humans. For investors, the start of a first-in-human study is a key de‑risking step in a biotech’s pipeline — it can affect development timelines, future data-readout expectations, and how the market values the program — while outcomes and funding needs will determine subsequent steps.