Soleno submits NDA to FDA for DCCR to treat Prader-Willi Syndrome

SOLENO THERAPEUTICS INC

NDA submitted for DCCR (diazoxide choline) extended-release tablets for PWS in patients aged 4+ with hyperphagia.
DCCR holds Breakthrough Therapy and Fast Track designations in the U.S.; Orphan Drug designation in U.S. and EU.
FDA has 60 days to determine if NDA will be accepted; Soleno requested Priority Review (6-month target review).
CEO Anish Bhatnagar called the submission a significant milestone for Soleno and the PWS community.

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