Biomea Fusion Down 61% on Clinical Hold for Diabetes Drug
By Josh Beckerman
Biomea Fusion shares fell 61% to $4.40 after hours as the company said the Food and Drug Administration placed a full clinical hold on Phase I/II clinical trials of diabetes drug BMF-219.
The FDA cited deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed dose escalation phase of one of the two studies.
"We respect the FDA's decision and agree that patient safety is paramount and our top priority" Biomea said, and it is working with the FDA "to put a plan in place as quickly as possible to ensure patient safety."
The company said results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
June 06, 2024 17:14 ET (21:14 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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