Shares of Biomea Fusion Inc (NASDAQ:BMEA) are trading sharply higher on Monday following an operational milestone for its lead metabolic drug program.
Here’s what investors need to know.
- Biomea Fusion shares are powering higher. What’s behind BMEA gains?
COVALENT-211 Reaches Full Enrollment With Topline Data Expected In Q1 2027
The clinical-stage biopharmaceutical firm announced that it has completed patient enrollment for COVALENT-211, its randomized, double-blind, placebo-controlled Phase II trial evaluating its oral menin inhibitor, icovamenib.
The trial enrolled 64 participants with insulin-deficient type 2 diabetes (T2D) who are inadequately controlled on standard-of-care background therapies. Biomea expects to report 26-week primary endpoint topline data in the first quarter of 2027.
Upcoming Clinical Milestones Focus on Beta-Cell Restoration
Management highlighted that the milestone keeps the broader Phase II diabetes development plan on track. Its companion Phase II study, COVALENT-212, evaluating icovamenib in T2D patients who fail to achieve glycemic targets on GLP-1 therapy, remains ongoing and is projected to finish enrollment before the end of the year, with 26-week topline results expected in second-quarter 2027.
Both trials build on earlier Phase II data showing that a 12-week course of icovamenib yielded durable, placebo-adjusted HbA1c reductions of up to 1.5% and 1.8% at Week 52 while increasing C-peptide levels.
BMEA Shares Surge Monday
Biomea Fusion shares were up 16.06% at $1.59 at market close Monday, according to Benzinga Pro data.
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