BMEA News & Events

Biomea Fusion announced that Juan Pablo Frias, MD, delivered an oral presentation at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona on March 14, 2026 highlighting positive 52-week follow-up results from the Company's Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes. The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment. Among the severe insulin-deficient patients, icovamenib achieved anHbA1c reduction that improved over time reaching 1.2% at Week 52. The strongest performing arm for this prespecified population was Arm B, with a mean HbA1c reduction of 1.5%. Severe insulin-deficient diabetes is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need.

Biomea Fusion outlined its execution priorities for 2026. The Company enters the year with strong operational momentum and a defined plan across its investigational metabolic programs, led by icovamenib, a potentially first-in-class investigational covalent menin inhibitor for diabetes, and BMF-650, an oral next-generation GLP-1 receptor agonist candidate in clinical development for obesity and metabolic disorders. Biomea remains focused on disciplined execution of its development strategy, advancing medicines designed to modify the underlying biology of diabetes and obesity with the goal of delivering durable clinical benefits. Key highlights: Advancing icovamenib toward late-stage clinical development in two Phase II clinical trials in patients with insulin-deficient type 2 diabetes and in T2D patients currently failing glucagon-like peptide-1 based therapies; Successfully completed icovamenib food-effect study, establishing optimal dosing conditions to support late-stage clinical studies; Successfully completed icovamenib chronic toxicology studies, supporting potential flexibility to evaluate clinical dosing beyond the validated 12-week regimen; Advancing BMF-650 through clinical development as an oral next-generation GLP-1 receptor agonist candidate designed to deliver effective and patient-friendly metabolic benefits