Fractyl Health(US:GUTS)2025-03-04 01:01Company Overview - Fractyl Health is developing therapies to address the $250 billion untapped market in weight maintenance[5,8] - The company is developing Revita, an outpatient endoscopic procedure, and Rejuva, a one-time pancreatic gene therapy platform for T2D and obesity[5] - Key clinical milestones are expected in 2025[5] Revita Program - Revita is a procedural therapy targeting gut dysfunction, a root cause of obesity and T2D[5,12,13] - Pooled data from Revita clinical studies demonstrate durable weight maintenance[9] - The REMAIN-1 pivotal study midpoint data is expected in Q2 2025, with full study enrollment in summer 2025[9] - Only 14% of patients are interested in weight loss drugs if informed about the risk of weight regain after stopping them[21] Rejuva Program - Rejuva is a pancreatic gene therapy platform with potential for one-time treatment of T2D and obesity[5,46] - The company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in H1 2025 and expects preliminary data in 2026, assuming CTA authorization[9,48,73] - Preclinical data shows RJVA-001 efficacy in db/db and DIO mouse models of T2D and obesity is superior to chronic semaglutide[73] - Local delivery of Rejuva enables low viral genome dosing with limited systemic virus exposure[54]