Next anticipated Revita ® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for
Authorization advances Fractyl Health to a dual clinical-stage company, with Revita ® in pivotal development for post-GLP-1 weight maintenance and Rejuva ® entering first-in-human studies for type 2 diabetes First-in-human dosing and preliminary data expected in the second half of 2026, subject to
BURLINGTON, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that it will report financial results for the
Completed randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026 Received favorable FDA feedback on De Novo classification request; De Novo submission expected in late Q4 2026 Reports new post-hoc analyses from REMAIN-1 Midpoint Cohort showing statistically
BURLINGTON, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced that it will report financial results for the fourth