Biomea Fusion: FDA Lifts Hold on Diabetes-Treatment Trials

By Connor Hart

Biomea Fusion said the Food and Drug Administration lifted its clinical hold on continuing clinical trials of the company's diabetes drug.

The FDA in June put the biopharmaceutical company's trials on hold, citing deficiencies based on the level of possible drug-induced liver damage observed in the completed dose-escalation phase of one of the two studies.

Chief Executive Thomas Butler on Thursday said the in-depth review of data confirmed the Redwood City, Calif, company's belief that the treatment, called BMF-219, is a first-in-class agent for the treatment of diabetes.

"We are encouraged from the safety review of the ongoing Phase 2b Expansion Study, where the concerning safety signals seen in the Phase 2a Escalation Study did not translate over to the larger Expansion Study," Butler said in a news release. "And most importantly, none of the elevated lab values translated to confirmed serious liver injury or liver impairment."

Shares were up 11.2% at $9.75 in afternoon trading.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

September 26, 2024 14:40 ET (18:40 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.