Soleno gets FDA Breakthrough Therapy Designation for DCCR in Prader-Willi Syndrome

SOLENO THERAPEUTICS INC

FDA grants Breakthrough Therapy Designation for DCCR (diazoxide choline) in adults/children ≥4 yrs with PWS and hyperphagia.
First ever Breakthrough Therapy Designation for a drug developed for PWS; based on Phase 3 program data.
NDA submission for DCCR in PWS remains on track for mid-2024.
DCCR also has Orphan Drug Designation in US and EU and Fast Track Designation in US.

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