Biomea Fusion Inc’s stock surged 27% on Monday after the company announced the completion of patient enrollment in its Phase II COVALENT-211 diabetes trial.
The trial, which evaluates the investigational small-molecule drug icovamenib at a 100 mg once-daily dose, enrolled 64 participants across 18 clinical sites. Participants were randomized in a 2:1 ratio to receive either icovamenib or a placebo over a 12-week treatment period, with a primary 26-week endpoint.
Analyst Joseph Pantginis at H.C. Wainwright maintained a Buy rating and set a price target of $4.00, citing the potential for icovamenib to replicate prior efficacy signals. In the earlier COVALENT-111 trial, icovamenib demonstrated durable HbA1c reductions persisting nine months post-treatment, including placebo-adjusted mean reductions of up to 1.5% in severe insulin-deficient type 2 diabetes patients and up to 1.8% in patients on GLP-1 RA-based therapies not meeting glycemic targets.
Biomea Fusion is also advancing a second Phase II trial, COVALENT-212, with enrollment expected to conclude by year-end. Topline results for both COVALENT-211 and COVALENT-212 are anticipated in the first and second quarters of 2027, respectively.
Icovamenib is being developed as an orally administered, disease-modifying therapy targeting β-cell restoration in defined type 2 diabetes subtypes, positioning it as a potential first-in-class treatment.
