- 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.
‘Executive Order: Declaring A Disaster In The State Of New York’
https://www.governor.ny.gov/executive-order/no-21-declaring-disaster-state-new-york
E X E C U T I V E O R D E R
DECLARING A DISASTER IN THE
