(RTTNews) - Biomea Fusion Inc. (BMEA) announced that the U.S. Food and Drug Administration has lifted the clinical hold on the company's ongoing Phase I/II clinical trials of the Company's investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.
BMEA closed Thursday's regular trading at $9.57 up $0.80 or $9.12%.
The company noted that the in-depth review of the clinical data to date reconfirmed its confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes. The company is encouraged from the safety review of the ongoing Phase 2b Expansion Study, where the concerning safety signals seen in the Phase 2a Escalation Study did not translate over to the larger Expansion Study.
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