Biomea Fusion, Inc. (NASDAQ:BMEA) saw its stock drop by 60.3% pre-market on Friday after the United States Food and Drug Administration (FDA) imposed a full clinical hold on its Phase I/II trials for BMF-219, a diabetes treatment.

What Happened: The FDA’s decision was driven by concerns over potential drug-induced hepatotoxicity observed during the Dose Escalation Phase of the trials, according to their press release. Elevated liver enzyme levels were noted, although most adverse events were mild to moderate, with no severe reactions reported.

At the time of writing, Biomea Fusion’s stock was trading at $4.470, down from $11.27 at Thursday’s close, Benzinga Pro data revealed.

The trials, COVALENT-111 and COVALENT-112, are investigating BMF-219 in type 2 and type 1 diabetes, respectively. Despite the hold, Biomea Fusion will continue to gather safety and efficacy data.

Thomas Butler, CEO and Chairman of Biomea Fusion stressed the company’s dedication to patient safety and its ongoing collaboration with the FDA to resume the studies. He highlighted BMF-219’s potential in restoring glucose-controlled insulin production and improving glycemic control.

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This story was generated using Benzinga Neuro and edited by Pooja Rajkumari