Soleno Therapeutics seeking regulatory approval in treatment of PWS

Soleno Therapeutics (SLNO) “announced that Soleno’s Marketing Authorization Application seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets for the treatment of adults and children four years and older with Prader-Willi syndrome who have hyperphagia had been validated by the European Medicines Agency.” “The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU,” said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “Based on the data generated, DCCR has the potential to help treat hyperphagia, which is the most life-limiting aspect of PWS. We look forward to working closely with European regulators during the review process and intend to make DCCR available to patients in the EU as expeditiously as possible, if approved.”