Tonix Pharmaceuticals receives Rare Pediatric Disease designation for TNX-2900

Tonix Pharmaceuticals announced the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to TNX-2900, a proprietary magnesium potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.