NasdaqGM:GUTSMedical Equipment
Fractyl Health (GUTS) Is Down 78.0% After Positive REMAIN-1 Midpoint Data And De Novo FDA Plan - Has The Bull Case Changed?
On 29 January 2026, Fractyl Health reported positive six-month randomized midpoint data from its REMAIN-1 study, showing Revita-treated patients had less weight regain and better cardiometabolic markers than sham after stopping GLP-1 drugs, and outlined plans to seek FDA De Novo classification.
An interesting angle is that Revita is being explored specifically as a tool to help maintain weight loss after GLP-1 discontinuation, targeting a growing clinical gap.
Against this backdrop, we’ll...