04:52 AM EDT, 06/07/2024 (MT Newswires) -- (Updates with the stock move in the headline and the first paragraph.)

Biomea Fusion ( BMEA ) shares were down more than 58% in premarket activity Friday after the company overnight reported that the US Food and Drug Administration notified a full clinical hold was placed on phase I/II trials of its investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes.

The FDA cited deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed dose escalation phase of COVALENT-111, the company said late Thursday, adding that higher doses, various food intake regimens, medical history, and concomitant medications may have contributed to observed liver enzyme elevations.

"We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA," said CEO Thomas Butler.

Price: 4.65, Change: -6.62, Percent Change: -58.74