FDA Pushes Decision Date For Reata's Genetic Neuromuscular Disease Candidate

  • The FDA has extended the review timeline for Reata Pharmaceuticals Inc's 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.
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