On March 25, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to its product candidate TNX-2900 for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. This designation follows the previous Orphan Drug designation by the FDA in 2022 and the clearance of the investigational new drug (IND) application in 2023. The Rare Pediatric Disease Designation could potentially lead to a transferable Priority Review Voucher for Tonix, which has recently been valued at around $100 million in sales. The FDA's recognition of TNX-2900 addresses the unmet medical need for PWS hyperphagia, for which there are currently no approved treatments. Tonix Pharmaceuticals, based in Chatham, New Jersey, is focused on developing therapeutics for central nervous system disorders and other areas, with a commercial subsidiary marketing products for acute migraine treatment.

On March 25, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to its product candidate TNX-2900 for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. This designation follows the previous Orphan Drug designation by the FDA in 2022 and the clearance of the investigational new drug (IND) application in 2023. The Rare Pediatric Disease Designation could potentially lead to a transferable Priority Review Voucher for Tonix, which has recently been valued at around $100 million in sales. The FDA's recognition of TNX-2900 addresses the unmet medical need for PWS hyperphagia, for which there are currently no approved treatments. Tonix Pharmaceuticals, based in Chatham, New Jersey, is focused on developing therapeutics for central nervous system disorders and other areas, with a commercial subsidiary marketing products for acute migraine treatment.