US FDA lifts clinical hold on Biomea's diabetes trials (updated)

Biomea Fusion

26/09/2024 19:18

(Adds details on the drug and trial in paragraphs 2-4)
       Sept 26 (Reuters) - Biomea Fusion  BMEA.O  said on
Thursday the U.S. Food and Drug Administration lifted a clinical
hold on ongoing studies of its experimental drug for type 1 and
2 diabetes, sending its shares up 3.2%.
    The drug, BMF-219, is being tested in an early-to-mid stage
study for type 2 diabetes and a mid-stage study for type 1
diabetes.
    The hold was placed by the regulator in June due to liver
toxicity concerns.
    "None of the elevated lab values translated to confirmed
serious liver injury or liver impairment," said CEO Thomas
Butler.

 (Reporting by Puyaan Singh in Bengaluru; Editing by Alan
Barona)
 ((Puyaan.Singh@thomsonreuters.com))