Fractyl Health (NASDAQ:GUTS) has announced plans to prioritize its REMAIN-1 pivotal study, advance its novel Rejuva gene therapy platform into first-in-human studies, and pause investment in its Revita programs for Type 2 diabetes (T2D), aiming to extend its cash runway into 2026 through multiple clinical milestones.
The REMAIN-1 pivotal study is addressing the growing demand for alternatives to GLP-1 drugs. Fractyl reports significant demand for participation in the study from patients and physicians.
Harith Rajagopalan, co-founder and CEO of Fractyl, stated, “The real challenge in obesity is no longer losing weight, it is keeping the weight off. The strong response from patients and physicians to the REMAIN-1 study highlights the urgent need for durable weight maintenance solutions, and we are doubling down on our efforts in this space.”
“Revita is the first therapeutic candidate to receive Breakthrough Device designation for weight maintenance, and we are uniquely positioned to address this critical gap. By prioritizing REMAIN-1 and advancing our groundbreaking Rejuva gene therapy platform, we are channeling our resources toward what we believe are the most impactful and differentiated opportunities. Given the rapidly evolving obesity landscape, we are pausing investment in our Revita programs for T2D and sharpening our focus. We believe these strategic steps will enable us to execute on our mission of delivering truly transformative solutions for patients with obesity and metabolic disease,” he added.
