Fractyl Health Reports First Quarter 2026 Financial Results and Business Updates

May 12, 2026 - 20:20

Fractyl Health has released its financial results for the first quarter of 2026, alongside a series of business updates focused on its metabolic disease pipeline. The company outlined specific timelines for upcoming clinical data readouts for its lead product candidate, Revita.

According to the update, the next anticipated data from the Revita program includes 1-year results from the REVEAL-1 Cohort, expected in the second quarter of 2026. Following that, the company plans to release 1-year randomized data from the REMAIN-1 Midpoint Cohort in the third quarter of 2026. Looking further ahead, Fractyl reaffirmed its expectations for the fourth quarter. The company anticipates topline 6-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026. Later in that same quarter, the company aims to submit a De Novo marketing application to the FDA for use in post-GLP-1 weight maintenance.

In addition to the Revita updates, Fractyl provided news on its gene therapy program, RJVA-001. The company announced that it has received Clinical Trial Application authorization in the Netherlands for a first-in-human study of RJVA-001. This study is designed for patients with type 2 diabetes, and the company confirmed that the first patient has already been dosed in the trial.