FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “Reata Pharmaceuticals, Inc. Surges as FDA Requests Preliminary Drug Meeting”
Reata Pharmaceuticals, Inc. (NASDAQ: RETA) surged over 13% in premarket trading after the company announced that the FDA Has Asked The Company to Request a Pre-NDA Meeting for Omaveloxolone for the Treatment of Friedreich’s Ataxia.
The Division of Neurology Products 1 of the U.S. FDA suggested that the Company withdraw the current meeting request for a Type C meeting and instead request a pre-NDA meeting, which the Division will grant upon receipt.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl (“bardoxolone”) and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Reata possesses exclusive, worldwide rights to develop, manufacture, and commercialize omaveloxolone, and our other next-generation Nrf2 activators. Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.
For more information, please visit: Reata Pharmaceuticals, Inc.
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