Fractyl Health (NASDAQ:GUTS) said it remains on track to report pivotal data for its Revita therapy in early fourth quarter 2026, as management highlighted clinical, regulatory and reimbursement developments...
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...
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...
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...
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...