Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a global biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the Prior Approval Supplement (PAS) to update the drug substance specification for SKYCLARYS® (omaveloxolone). As per the US Code of Federal Regulation, the filing means FDA has made a threshold determination that the PAS is sufficiently complete to permit a substantive review. As previously communicated, the PAS is being reviewed under expedited Priority Review with a target action date of mid-August 2023.
Reata is a global biopharmaceutical company committed to developing and commercializing novel therapeutics for patients with serious or life-threatening diseases with few or no approved therapies. We focus on molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata developed the first and only U.S. Food and Drug Administration approved product for Friedreich’s ataxia. In addition, Reata is developing cemdomespib for the treatment of patients with diabetic neuropathic pain and Nrf2 activators for neurological diseases. Cemdomespib is an investigational drug, and its safety and efficacy has not been established by any regulatory agency. For more information visit www.reatapharma.com and follow us on LinkedIn and Twitter.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, our plans and objectives for the commercialization of SKYCLARYS and the timing thereof, our expectations regarding the size of the patient population for SKYCLARYS, and our plans to research, develop, and commercialize our other product candidates. You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans,” “model,” and “expects.” Forward-looking statements are based on Reata’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the potential market size and the size of the patient population for SKYCLARYS and the market opportunities for SKYCLARYS; (ii) our ability to successfully build our commercial infrastructure to manufacture, market and sell SKYCLARYS, including the successful development and implementation of our sales and marketing campaigns for SKYCLARYS; (iii) the ability of our third-party suppliers and contract manufacturers to manufacture SKYCLARYS at the required quality and quantities and in compliance with applicable laws and regulations; and (iv) other factors set forth in Reata’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, under the caption “Risk Factors.” The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.