Fractyl Health Sharpens Focus on Revita Following Positive Pivotal Results, Advancing Toward Planned FDA De Novo Submission in Post-GLP-1 Weight Maintenance

Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health

“We believe the positive pivotal results from REMAIN-1 represent a defining moment for Fractyl and represent an enormous opportunity for Revita potential to fundamentally change how obesity is treated and offer a durable approach to weight maintenance”

Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health

“A million patients per month in the United States face the challenge of weight regain after discontinuing GLP-1 therapies.”

Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health

“Our goal is for Revita to establish an entirely new therapeutic category by aiming to reverse years of diet-induced damage to the gut.”

Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health

“We expect the capital we have today to be sufficient to fund our planned De Novo submission and upcoming 12-month pivotal data, and we are excited to focus our attention and align our resources behind our near-term opportunity.”

Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health

“While these decisions are difficult, particularly those impacting our colleagues, we believe this focused strategy will position Fractyl to operate more efficiently and advance Revita toward its clinical and commercial potential.”