FDA Grants Orphan Drug Designation to Tonix Pharmaceuticals

Mar 3, 2022 By MarketDepth

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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) today announced that the U.S. Food and Drug Administration (FDA)  has granted an Orphan-Drug Designation for TNX-2900.

Stock Sruged 46%

Shares Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) gained over 46% following the announcement.

Usage by Children and Adults

Designed for the treatment of Prader-Willi syndrome, TNX-2900 is based on Tonix’s patented intranasal potentiated oxytocin formulation intended for use by adults and adolescents. There is currently no approved treatment for either the suckling deficit in babies or the obesity and hyperphagia in older children associated with Prader-Willi syndrome.

“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. It underscores the urgent, unmet medical need for patients diagnosed with this disease, and will benefit us as we continue to advance our program.”

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals

Overall, the newly granted orphan drug designation provides Tonix Pharmaceuticals with certain development incentives,and potential market exclusivity for seven years, if approved.