Reata says no plans for FDA advisers' meeting on rare disease drug, shares up

Reata Pharmaceuticals

14/10/2022 17:39

** Shares of drug developer Reata Pharmaceuticals  RETA.O 
rise as much as 22.2% to $30.6
    ** Co disclosed FDA does not plan to hold an advisory
committee meeting in connection with its review of RETA's
application for approval of Omaveloxolone  urn:newsml:reuters.com:*:nBw9mxG1Ha
    ** Omaveloxolone is co's experimental drug for treatment of
a rare neurological disorder called Friedreich's ataxia
    ** In August, after the FDA raised concerns about efficacy
data in co's application, RETA submitted further data; the
planned advisory committee meeting was put on hold pending
review of new data  urn:newsml:reuters.com:*:nBw2Dffn3a
    ** Though there are no certainties on FDA's action on
approval, Jefferies remains "cautiously optimistic"; says "no
adcom at this mid-stage could be viewed as a win"
    ** The FDA is expected to deliver a decision on
Omaveloxolone's approval by February 28, 2023 
    ** Including session's gain, RETA up 11.7% YTD
 (Reporting by Nandhini Srinivasan in Bengaluru)
 ((nandhini.srinivasan@thomsonreuters.com))