FDA places full clinical hold on Biomea Fusion's BMF-219 diabetes trials due to liver enzyme elevations

Biomea Fusion, Inc.

Full clinical hold on Phase I/II COVALENT-111 and COVALENT-112 for BMF-219 in type 2 and type 1 diabetes.
FDA cited potential drug-induced hepatotoxicity; higher doses up to 400 mg may have contributed to liver enzyme elevations.
Most adverse events mild to moderate; no serious adverse reactions reported to date with BMF-219.
Company continues data collection during hold; collaborating with FDA to resolve clinical hold quickly.

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