Fractyl Health Focuses on Revita, Cuts Workforce

Burlington, Mass., USA - Fractyl Health, Inc. (Nasdaq: GUTS), a clinical-stage metabolic therapeutics company, announced a strategic reprioritization to concentrate its resources on advancing Revita toward a planned FDA De Novo submission in post-GLP-1 weight maintenance.

The decision follows positive topline six-month results from the REMAIN-1 pivotal cohort, which met its prespecified co-primary endpoint. To support this focus, the company is implementing a workforce reduction of approximately 45%, discontinuing internal development of its Rejuva gene therapy program, and seeking strategic alternatives for it. These measures are expected to reduce quarterly cash burn by about 50% and extend the cash runway into the second quarter of 2027.

Key Highlights

• Planned FDA De Novo submission for Revita in late Q4 2026.
• Anticipated 12-month pivotal data readout in Q1 2027.
• Workforce reduction of approximately 45% to align organization behind Revita.
• Operating cash burn expected to drop to approximately $8 million by the end of Q2 2027.