Fractyl Health said it has completed participant randomization in the REMAIN-1 Pivotal Cohort, a randomized, double-blind, sham-controlled study of its Revita procedure for weight maintenance after discontinuation of GLP-1 therapy. Adults with obesity (BMI at least 30 kg/m² and no more than 45 kg/m²) who achieved at least 15% total body weight loss on tirzepatide were randomized 2:1 to Revita or a sham endoscopic procedure. The co-primary endpoints are percent total body weight regain at six months (Revita versus sham) and the proportion of participants maintaining at least 5% total body weight loss at 12 months. The company said topline six-month pivotal data are expected in early Q4 2026 and a potential FDA marketing application submission is expected in late Q4 2026, and it reiterated cash runway guidance into early 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Fractyl Health Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602260700PRIMZONEFULLFEED9661792) on February 26, 2026, and is solely responsible for the information contained therein.