- The FDA has extended the review timeline for Reata Pharmaceuticals Inc’s (NASDAQ:RETA) marketing application seeking approval for omaveloxolone for Friedreich’s ataxia by three months.
- The company recently submitted an updated Delayed-Start Analysis of the MOXIe Extension study using a March 2022 data cut-off, a new Propensity-Matched Analysis of MOXIe Extension data, and an analysis of the relevance of Nrf2, the target of omaveloxolone, to the pathophysiology of Friedreich’s ataxia.
- Related: Why Reata Pharma Shares Are Trading Lower After Q2 Earnings Update?
- These submissions were provided as confirmatory evidence of the results of the MOXIe Part 2 study in response to concerns raised by the FDA during the mid-cycle communication meeting.
- The updated PDUFA date for the application is February 28, 2023. The FDA put the planned advisory committee meeting on hold pending a review of the new amendments.
- Price Action: RETA shares are down 8.40% at $22.04 during the market session on the last check Tuesday.
HanesBrands Announces Evaluation Of Strategic Options For Global Champion Business
HanesBrands (NYSE:HBI) today announced that its Board of Directors and executive leadership team, with the assistance of financial and legal advisors, are undertaking an evaluation of strategic options for the global
