Globenewswire·2026-01-05 12:00Core Insights - Fractyl Health is positioned for a significant year in 2026, focusing on clinical and regulatory milestones for its Revita and Rejuva programs [2][3] Financial Overview - As of December 31, 2025, Fractyl had approximately $81.5 million in cash and cash equivalents, which increased to $85.6 million following the exercise of Tranche A warrants [6][8] - The current cash runway is expected to support operations through early 2027 [8] Revita Program - The Revita program aims to address post-GLP-1 weight maintenance, with pivotal data and potential PMA filing expected in H2 2026 [2][3] - Key milestones for Revita in 2026 include: - Late January: 6-month randomized data from the REMAIN-1 Midpoint Cohort - Early 2026: Completion of randomizations for the REMAIN-1 Pivotal Cohort - Q2 2026: 1-year REVEAL-1 Cohort data - Q3 2026: 1-year REMAIN-1 Midpoint Cohort data - H2 2026: Topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and potential PMA filing [6][10] Rejuva Program - The Rejuva gene therapy platform is advancing towards clinical validation, with the first-in-human evaluation of RJVA-001 expected in 2026, pending regulatory authorization [5][11] - Key milestones for Rejuva in 2026 include: - Q2 2026: Regulatory feedback on the Clinical Trial Application (CTA) for RJVA-001 - H2 2026: First-in-human dosing of RJVA-001 and preliminary data [7][11] Company Overview - Fractyl Health focuses on innovative treatments for metabolic diseases, particularly obesity and type 2 diabetes (T2D), aiming to transform treatment from chronic management to disease-modifying therapies [9][10] - The company has a robust intellectual property portfolio, with 35 granted U.S. patents and approximately 45 pending applications [9]