Globenewswire·2026-01-12 13:00Core Insights - Biomea Fusion, Inc. is entering 2026 with strong operational momentum and a clear plan for its investigational metabolic programs, focusing on icovamenib and BMF-650 [1][2] Icovamenib Development - Icovamenib is a potentially first-in-class covalent menin inhibitor that promotes beta-cell proliferation and improves beta-cell function, targeting insulin-deficient diabetes [3][4] - Recent 52-week data indicates sustained glycemic improvement in patients with insulin deficiency, reinforcing its differentiated approach [3][4] - The therapy has shown clinically meaningful benefits for patients on GLP-1 therapies who have not achieved glycemic targets, supporting its use alongside incretin-based treatments [4] - A food-effect study demonstrated optimal pharmacokinetic exposure and a favorable safety profile, which is crucial for upcoming Phase II studies [5][6] - Over 400 subjects have been dosed with icovamenib, indicating a generally well-tolerated safety profile [6] BMF-650 Development - BMF-650 is an oral next-generation GLP-1 receptor agonist designed for effective and patient-friendly metabolic care [7][8] - Initial 28-day weight loss clinical data from the Phase I study in obese volunteers is expected in Q2 2026 [8] 2026 Milestones - The company plans to advance icovamenib in two Phase II clinical trials, COVALENT-211 and COVALENT-212, with first patient enrollment expected in Q1 2026 and readouts anticipated in Q4 2026 [14] - Continued proactive regulatory engagement and collaboration with clinical experts will support progression toward late-stage development [14]