Biomea’s Novel Diabetes Candidate Placed On FDA Hold

Biomea reported that the FDA placed a clinical hold on two ongoing Phase I/II diabetes studies of menin inhibitor BMF-219 due to concerns about liver toxicity.

Delay
Biomea's diabetes candidate ran into a delay as the FDA placed two trials on hold • Source: Shutterstock

Biomea Fusion, Inc. hit a potentially damaging bump in the road on 6 June, revealing that the US Food and Drug Administration placed BMF-219, testing a novel mechanism of action for type 1 and type 2 diabetes, on full clinical hold due to concerns about elevated liver enzymes in a Phase I/II study.

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