On September 13, 2017 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or “the Company”), a clinical-stage biopharmaceutical company, reported that the United States Food and Drug Administration (“FDA”) has granted orphan designation to omaveloxolone for the treatment of Stage IIb through IV malignant melanoma (Press release, Reata Pharmaceuticals, SEP 13, 2017, View Source [SID1234520527]).

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Reata is currently executing a Phase 1b/2 trial evaluating the safety and efficacy of omaveloxolone in combination with nivolumab or ipilimumab in patients with unresectable or metastatic melanoma who have failed anti-PD-(L)1 therapies. The purpose of the Phase 1b portion of the trial is to identify a recommended Phase 2 dose by collecting blood, tumor biopsy, and radiographic data to determine if omaveloxolone can unmask tumors, restore immune response, and demonstrate anti-cancer activity.

Orphan status is granted to treatments for diseases that affect fewer than 200,000 people in the United States and provides specific incentives for therapies intended for the treatment, diagnosis, or prevention of rare diseases. The orphan designation will provide Reata with development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.