Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) operates as a clinical-stage biopharmaceutical company, which is focused on the research, discovery, licensing, development, and acquisition of therapies for a wide range of diseases and ailments. Shares of the biopharma company are surging 79% through early trading on Thursday, March 3, 2022. Over the past three months, Tonix Pharmaceuticals has seen average daily volume of 16.95 million. However, volume of 148.07 million shares or dollar volume of around $50.34 million, has already exchanged hands through early trading.
Shares of Tonix Pharmaceuticals are soaring after the company announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the company’s TNX-2900 candidate for the treatment of Prader-Willi syndrome.
The Orphan Drug Designation was granted after Tonix entered into a sponsored research agreement with Inserm Transfert and Aix-Marseille University to study oxytocin in a genetically engineered mouse model of Prader-Willi syndrome.
Widely recognized as a common genetic that could lead to life-threatening childhood obesity, Prader-Willi syndrome has shown to be frequent across males and females of all ages, races, and ethnicities. In infants, Prader-Willi syndrome can cause lack of suckling. For children and adults, the illness can cause severe hyperphagia, a strong physiological drive to eat, which leads to obesity.
“Orphan-Drug Designation by the FDA is an important milestone and further validates our efforts to investigate the utility of TNX-2900 for Prader-Willi syndrome,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “It underscores the urgent, unmet medical need for patients diagnosed with this disease, and will benefit us as we continue to advance our program.”
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