Developments at Reata Pharmaceuticals

Texas, USA-based drug developer Reata Pharmaceuticals (Nasdaq: RETA) says that the US Food and Drug Administration (FDA) accepted for filing the Prior Approval Supplement (PAS) to update the drug substance specification for Skyclarys (omaveloxolone). Reata’s shares edged up 2.6% to $96.01 on the news in pre-market activity.

As per the US Code of Federal Regulation, the filing means the FDA has made a threshold determination that the PAS is sufficiently complete to permit a substantive review. As previously communicated, the PAS is being reviewed under expedited Priority Review with a target action date of mid-August 2023.

The FDA granted approval of Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older in March this year.