U.S. FDA places hold on Biomea's diabetes trial (updated)

Biomea Fusion

06/06/2024 21:29

(Adds details about hold throughout)
       June 6 (Reuters) - Biomea Fusion  BMEA.O  said on
Thursday the U.S. Food and Drug Administration had placed a
clinical hold on its ongoing early-to-mid stage study of its
experimental drug for type 1 and 2 diabetes, sending its shares
down 60% in extended trade.
    The drug developer said the FDA cited deficiencies based on
the level of possible drug-induced toxic liver disease observed
in the completed dose escalation phase of the trial.
        Higher doses of up to 400 milligrams, various food
intake regimens, medical history and accompanying medications
may have contributed to observed liver enzyme elevations, the
company said.
  

 (Reporting by Puyaan Singh in Bengaluru; Editing by Maju
Samuel)
 ((Puyaan.Singh@thomsonreuters.com;))