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...
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...
Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash runway guidance into early 2027, beyond...
The DJS Law Group announces that it is investigating claims on behalf of investors of Fractyl Health, Inc. (“Fractyl Health” or “the Company”) (NASDAQ: GUTS ) for violations...
The DJS Law Group announces that it is investigating claims on behalf of investors of Fractyl Health, Inc. (“Fractyl Health” or “the Company”) (NASDAQ: GUTS ) for violations...
Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability...
BURLINGTON, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pattern-breaking approaches...
Randomized 6-month data from the REMAIN-1 Midpoint Cohort expected in late January 2026 Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected in H2 2026 ...
BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company” or “Fractyl”), a metabolic therapeutics company focused on pioneering pattern-breaking...
Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment 1.5% mean weight change observed with...