CymaBay Therapeutics seeks US marketing approval for liver drug; shares up

CymaBay Therapeutics

15/12/2023 14:37

** Shares of CymaBay Therapeutics  CBAY.O  rise 2.3% to
$22.1 
    ** Co submits application to the U.S. Food and Drug
Administration (FDA) seeking approval to market its drug to
treat a type of chronic inflammatory liver disease 
    ** CBAY has sought a priority review of its application; if
accepted, the regulator would complete its review within 6
months of accepting the application
    ** Co says application is based on data from a late-stage
study that showed the drug showing a statistically significant
improvement in disease progression compared to a placebo
    ** Co plans to file a marketing application for the drug
with the European Medicines Agency (EMA) and U.K. Medicines and
Healthcare Products Regulatory Agency (MHRA) in the first half
of 2024
    ** As of last close, stock has more than tripled YTD

 (Reporting by Khushi Mandowara in Bengaluru)
 ((Khushi.Mandowara@thomsonreuters.com;))