04:56 PM EDT, 06/06/2024 (MT Newswires) -- Biomea Fusion ( BMEA ) said Thursday it received a notice from the US Food and Drug Administration that a full clinical hold has been placed on its 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, 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.

Shares of the company fell about 61% in recent after-hours activity.

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