89bio up on plans to advance NASH drug study after positive FDA feedback

89bio

04/12/2023 13:54

** Shares of drug developer 89bio  ETNB.O  up 11.3% at $9.4 
before the bell
    ** Co to begin late-stage lead drug study after receiving
positive feedback from U.S. health regulator to treat a type of
fatty liver disease
    ** Meeting with FDA supports advancement of its drug
candidate, pegozafermin, into late-stage trial planned to
initiate in H1'24- co
    ** NASH or non-alcoholic steatohepatitis is characterized by
the organ developing fibrosis or scarring, which can progress to
cirrhosis and liver failure
    ** FDA feedback also supports NASH development strategy,
including accelerated approval pathway for patients in F4 and
F2-F3 NASH stages
    ** Program will include two late-stage trials for F2-F3 and
the F4 NASH stages, expected to initiate in Q1 and Q2 of 2024 -
co
    ** Trials to include patients on background GLP-1 therapy to
assess potential for combination with co's lead drug
    ** As of last close, stock down 34% YTD

 (Reporting by Pratik Jain in Bengaluru)
 ((Pratik.Jain@thomsonreuters.com;))