Reata Pharma jumps on FDA request for meeting on genetic disorder drug

Reata Pharmaceuticals

19/05/2021 13:16

** Shares of drug developer  RETA.O  climb 15.8% to $95.98
and among top pct gainers across U.S. exchanges premarket
    ** To file for a pre-marketing application meeting with the
FDA and withdraw a request for a Type-C meeting to discuss its
treatment omaveloxolone for Friedreich's ataxia  urn:newsml:reuters.com:*:nGNX68vzRh
    ** Regulator said a pre-marketing application meeting is the
most appropriate format and will grant it upon receipt
    ** FDA said in Nov the findings of omaveloxolone did not
strengthen results of an earlier mid-stage study  urn:newsml:reuters.com:*:nL4N2IB3CE
    ** Omaveloxolone met the main goal of a mid-stage study in
2019, but FDA in August sought a second trial, saying it was not
convinced data from the trial will support single study approval
    ** Friedreich's ataxia is a rare, inherited,
life-shortening, debilitating and degenerative neuromuscular
disorder
    ** Stock down ~33% YTD

 (Reporting by Trisha Roy in Bengaluru)
 ((Trisha.Roy@thomsonreuters.com; within U.S. +1 646 223 8780,
outside U.S. +91 80 6182 3635;))