Biomea gains as FDA lifts clinical hold on diabetes trials

Biomea Fusion

26/09/2024 19:21

** Shares of drug developer Biomea Fusion  BMEA.O  up about
7% at $9.35 
    ** Co says U.S. Food and Drug Administration lifted a
clinical hold on its studies of an experimental drug, BMF-219,
for type 1 and type 2 diabetes 
    ** FDA had placed a clinical hold on the trials in June,
citing a possible risk of drug-induced toxic liver disease
observed in type 2 diabetes patients who were given
progressively higher doses of the drug 
    ** Co says FDA reviewed safety data from an expansion study
of type 2 diabetes patients which did not have any drug related
safety issues 
    ** "None of the elevated lab values translated to confirmed
serious liver injury or liver impairment," said CEO Thomas
Butler  
    ** Including session's moves, BMEA down ~36% YTD

 (Reporting by Bhanvi Satija in Bengaluru)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788))