Reata Pharmaceuticals (NASDAQ:RETA) announced that the U.S. Food and Drug Administration has accepted New Drug Application (NDA) for its lead drug candidate omaveloxolone for the treatment of patients with Friedreich's ataxia.
The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of Nov. 30, 2022.
Additionally, the FDA indicated that the agency is planning to hold an advisory committee meeting to discuss the application.
Warren Huff, Reata's Chief Executive Officer, said, "With the FDA's acceptance of our NDA for filing, omaveloxolone is now one step closer to potentially providing a treatment option for patients with Friedreich's ataxia, a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies.”
If approved, the company anticipates a commercial launch in early 2023.
The FDA grants Priority Review that shortens review of NDA to eight months from the time of submission versus a standard review timeline of 12 months, applicable for medicines that may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.
Price Check: Shares of Reata Pharmaceuticals are trading 5% higher at $28.15 in Thursday’s premarket session, according to Benzinga Pro.
