Reata Pharma's Omaveloxolone Gets Priority Review, FDA Decision On Nov.30

Reata Pharmaceuticals Inc. (RETA), a clinical-stage biopharmaceutical company, on Thursday, announced that its New Drug Application for Omaveloxolone has been accepted for priority review by the FDA, with a decision date set for November 30, 2022.

Omaveloxolone is proposed for the treatment of patients with Friedreich's ataxia.

Friedreich's ataxia, is a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies. There are an estimated 4,000 patients diagnosed with Friedreich's ataxia in the United States and 22,000 individuals globally.

If approved, the company is looking forward to commercially launch Omaveloxolone in early 2023.

The FDA has granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations to Omaveloxolone for the treatment of Friedreich's ataxia. The European Commission has granted Orphan Drug Designation to Omaveloxolone for the treatment of Friedreich's ataxia.

Shares of Reata Pharmaceuticals are currently trading in pre-market at $28.14, up $1.26 or 4.69 percent from the previous close.

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