Biomea Fusion Inc. (BMEA) has announced that the U.S. Food and Drug Administration has lifted the clinical hold on its ongoing Phase I/II clinical trials for the investigational covalent menin inhibitor BMF-219, targeting type 2 diabetes (COVALENT-111) and type 1 diabetes (COVALENT-112).
On Thursday, BMEA's stock closed at $9.57, reflecting a gain of $0.80 or 9.12%.
The company highlighted that a comprehensive review of clinical data has reinforced its confidence in BMF-219 as an innovative, first-in-class treatment for diabetes. The firm is particularly encouraged by the safety review of the ongoing Phase 2b Expansion Study, noting that worrisome safety signals observed in the Phase 2a Escalation Study did not persist in the larger Expansion Study.
