Fractyl Health Reports Third Quarter 2026 Financial Results and Business Updates
Globe Newswire•12/11/2026•16:05 ET
0
Key Highlights
- ➤REMAIN-1 met six-month co-primary endpoint with high statistical significance, p=0.0023
- ➤Revita participants retained approximately 80% of GLP-1-induced weight loss versus 67% for sham
- ➤Planned FDA De Novo submission targets late Q4 2026
- ➤Workforce reduction of approximately 45% accompanies discontinuation of internal Rejuva development
- ➤Cash runway extends into Q2 2027; quarterly operating cash spending targeted at approximately $8 million
Expert Statements
Harith Rajagopalan, Co-Founder, President and Chief Executive Officer of Fractyl
“There are approximately 1 million Americans discontinuing GLP-1s each month, and these individuals are at high risk of weight and metabolic rebound. In this context, we believe the positive pivotal results from REMAIN-1 represent a defining moment for Fractyl. In the most rigorous stress test we could conceive, a single Revita procedure met its six-month co-primary endpoint with high statistical significance”
Harith Rajagopalan, Co-Founder, President and Chief Executive Officer of Fractyl
“Armed with positive data, we have focused the Company around Revita’s post-GLP-1 weight maintenance opportunity. We expect the capital we have today to be sufficient to fund our planned De Novo submission and upcoming 12-month pivotal data and. Our goal is for Revita to potentially establish an entirely new therapeutic category of post-GLP-1 weight maintenance by aiming to reverse years of diet-induced damage to the gut.”
REMAIN-1 Pivotal Cohort met its six-month co-primary endpoint with high statistical significance (p=0.0023); Revita(®) participants retained approximately 80% of GLP-1-induced weight loss versus 67% for sham
Planned FDA De Novo submission in late Q4 2026; topline 12-month data from the REMAIN-1 Pivotal Cohort anticipated in Q1 2027
Get started
Create a free account to read the full story.