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Reata Pharmaceuticals Completes Rolling Submission of New Drug Application for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia

If Approved, Omaveloxolone Would Become the First Therapy Indicated for the Treatment of Patients with Friedreich’s Ataxia

Friedreich’s Ataxia Affects Approximately 5,000 Patients in the United States with an Estimated 4,000 Diagnosed Patients


PLANO, Texas--(BUSINESS WIRE)-- Reata Pharmaceuticals, Inc. (Nasdaq: RETA), (“Reata,” the “Company,” “our,” “us,” or “we”), a clinical-stage biopharmaceutical company, today announced the completion of the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. This NDA is supported by the efficacy and safety data from the MOXIe Part 1, Part 2, and MOXIe Extension studies. The FDA has granted Fast Track Designation and Orphan Drug Designation to omaveloxolone for the treatment of Friedreich’s ataxia.

"This NDA submission marks an important step toward making a treatment available for patients with Friedreich’s ataxia, a serious degenerative neuromuscular disorder with no approved therapies," said Warren Huff, Reata’s Chief Executive Officer. "I want to thank all those who made this possible, especially our patients with Friedreich’s ataxia, their families, and investigators, as well as our employees, for their tenacity and unwavering belief in the omaveloxolone clinical program. We look forward to the next steps on the path to making omaveloxolone available as a first-in-class therapy for Friedreich’s ataxia, pending approval."

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