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Thursday, October 13, 2022

Reata: FDA Won't Hold AdCom for Omaveloxolone for Friedreich’s Ataxia NDA

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it does not plan to hold an advisory committee meeting in connection with its review of the Company’s New Drug Application ("NDA") for omaveloxolone 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, and we are committed to our goal of working to secure approval for omaveloxolone for patients living with this severe disease," said Warren Huff, Reata’s Chief Executive Officer.

https://finance.yahoo.com/news/reata-pharmaceuticals-announces-fda-does-203700809.html

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