Reata Pharmaceuticals Inc (NASDAQ: RETA) gained ground after the company disclosed that the U.S. Food and Drug Administration has granted orphan designation to omaveloxolone for the treatment of malignant melanoma.
The drug maker, based out of suburban Dallas, is currently executing what it calls 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 idea behind 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 by the FDA 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.
As for what the name will do for Reata, it will go far in providing development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.
No officials from the company were available to comment on the FDA nod.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation.
Reata shares gathered 34 cents, or 1.1%. to $30.79, within a 52-week trading range of $18.51 to $41.60.
