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Soleno’s lead program, VYKAT XR (diazoxide choline extended-release tablets; formerly DCCR), received FDA approval in April 2025 for the treatment of hyperphagia associated with Prader-Willi syndrome in adults and children aged four years and older. The company has initiated commercial launch activities in the U.S., with over 268 patient start forms received within weeks of launch. A Marketing Authorization Application to the European Medicines Agency for DCCR/VYKAT XR was planned for Q2 2025[6]. Clinical data presented at ISPOR 2025 highlighted significant reductions in hyperphagia and favorable safety outcomes[8].
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