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.