Reata plan to submit an MAA to the EMA in the fourth quarter of 2022.

PLANO, Texas--(BUSINESS WIRE)-- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter of 2022 and provided an update on the Company’s business operations and clinical development programs.-- The FDA has granted Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation to omaveloxolone for the treatment of Friedreich’s ataxia. In March 2022, we completed the rolling submission of an NDA to the 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 2 trial and additional supporting data from the MOXIe Part 1 and MOXIe Extension trials.-- We have secured an agreement on our Pediatric Investigation Plan with the European Medicines Agency (“EMA”) Pediatric Committee, and we are continuing to complete the regulatory procedures and submissions required prior to filing a Marketing Authorization Application (“MAA”) in Europe for approval of omaveloxolone for the treatment of patients with Friedreich’s ataxia. We plan to submit an MAA to the EMA in the fourth quarter of 2022.

Reata plan to submit an MAA to the EMA in the fourth quarter of 2022.