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Biomea Fusion Reports Positive 52-Week Phase II Results for Icovamenib in Diabetes

Company-presented ATTD findings will guide dosing decisions for follow-on Phase II trials targeting defined patient groups.

Overview

  • Icovamenib showed a favorable 52-week safety profile in COVALENT-111 with no serious treatment-related adverse events, according to the company.
  • Subgroup analyses reported clinically meaningful HbA1c reductions, including a 1.2% drop at Week 52 in severe insulin-deficient patients and up to 1.5% with the most effective dosing regimen.
  • The company cited a durability signal nine months after dosing at Week 52, supporting continued development of the oral menin inhibitor.
  • Biomea Fusion said the data clarify an effective dose and target populations, informing plans for additional, more focused Phase II studies.
  • Shares rose 3.68% to $1.41 on Friday but remain down about 46% over 12 months, and the company is slated to provide its next financial update on March 30, 2026.