Reata Pharmaceuticals, Inc. (RETA), a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases, announced that it was communicated from the Division of Neurology Products 1 of the FDA focusing on the preliminary review of briefing materials for an approaching Type C meeting focusing on the development program for omaveloxolone in Friedreich’s ataxia. RETA stock price surged immensely adjacent to the news.
At last check in premarket trading, shares of Reata Pharmaceuticals Inc. (RETA) were up 14.22% at $94.70. RETA stock closed the last session at $82.91, increasing 4.86% or $3.84. Shares of the company fluctuated between $79.0001 and $85.66 throughout the day. The shares of Reata Pharmaceuticals Inc. have retreated -0.18% in the last five days; however, they have lost -9.09% over the last month.
About Friedreich’s Ataxia
FA is an uncommon, genetic, life-threatening, and degenerative neuromuscular disorder, which is usually diagnosed during the childhood period. FA is commonly caused by a trinucleotide repeat expansion in the first intron of the frataxin gene, which is responsible for encoding the mitochondrial protein frataxin.
Patients with FA experience several symptoms in adolescence, which may be inclusive of increasing loss of coordination, weakness in muscles, and fatigue, mostly causing motor incapacitation, with patients needing a wheelchair by late teens or early twenties.
FA patients may also experience visual issues, loss in hearing, diabetes, and cardiomyopathy. Based on research, FA affects almost 5,000 children and adults in USA with 22,000 patients worldwide. Presently, there is no approved therapies to treat FA.
Omaveloxolone is in a development phase, oral, taken once a day, an activator of Nrf2, a transcription factor that stimulates molecular pathways that enhance the resolution of inflammation by bringing back mitochondrial function, diminishing oxidative stress, and limiting pro-inflammatory signaling.
The FDA has complied with an Orphan Drug designation to omaveloxolone to treat Friedreich’s ataxia. The European Commission has granted Orphan Drug designation in Europe to omaveloxolone to treat FA as well.
Reata has gained global rights to develop, produce, and sell omaveloxolone, and our other latest Nrf2 activators. However, omaveloxolone is still an investigational drug, and its safety and tolerance have not been depicted by any agency.
FDA interest and compliance for reviewal of omaveloxolone to treat FA has immensely increased investor interest with REATA stock price increasing substantially at last check.