FRACTYL HEALTH, INC. 8-K

What Happened

• On February 26, 2026, Fractyl Health, Inc. (NASDAQ: GUTS) announced via press release that it has completed participant randomization in the REMAIN-1 Pivotal Cohort, a randomized, double‑blind, sham‑controlled study evaluating Revita® for weight maintenance after GLP‑1 therapy discontinuation. The company also provided updated guidance on 2026 Revita clinical and regulatory milestones and reiterated its cash guidance. The press release is furnished as Exhibit 99.1 to the company’s Form 8‑K.

Key Details

• Date filed: February 26, 2026 (Form 8‑K, Item 7.01 disclosure).
• Trial: REMAIN‑1 Pivotal Cohort — randomized, double‑blind, sham‑controlled study of Revita for weight maintenance following GLP‑1 discontinuation.
• Corporate update: Fractyl updated 2026 clinical and regulatory milestone guidance for Revita and reiterated its cash guidance (details provided in the company press release/exhibit).
• Exhibit: Press release furnished as Exhibit 99.1 to the Form 8‑K.

Why It Matters

• Completion of randomization is a material clinical milestone for a pivotal study, moving Revita closer to later‑stage results that can inform regulatory decisions.
• Updated 2026 clinical and regulatory milestones plus reiterated cash guidance give investors information about the company’s expected near‑term development timeline and financial runway for executing its Revita program.