Reata Pharma rises on regulatory update for genetic disease drug

Reata Pharmaceuticals

08/11/2022 18:42

** Shares of drug developer Reata Pharmaceuticals  RETA.O  
rises 23% to $42.81 - hitting their highest levels in nearly a
year 
    ** RETA says it recently completed a late-cycle meeting with
the U.S. Food and Drug Administration for its drug omaveloxolone
as a treatment of Friedreich's ataxia, a genetic rare disease 
        ** RETA says it is in the process of building necessary
infrastructure to support the drug's commercial launch 
    ** Co says FDA has not found any risk management issues to
date, and agency will convey post-marketing requirements and
label review comments to RETA by early 2023
    ** Adds that FDA reiterated that it does not plan to hold an
advisory committee meeting to discuss co's marketing application
for omaveloxolone 
    ** The FDA is expected to decide on approval for the drug by
Feb. 28, 2023
    ** RETA also plans to submit a marketing application to
European Medicines Agency for omaveloxolone this year
    ** Co reports Q3 net loss of $2.16 per share vs analysts'
estimates of $2.18 loss per share
    ** Including session's gains, stock up 51.9% YTD
 (Reporting by Aditya Samal)
 ((Aditya.Samal@thomsonreuters.com;))