FDA approves Soleno's VYKAT XR for hyperphagia in Prader-Willi syndrome

SOLENO THERAPEUTICS INC

VYKAT XR (diazoxide choline) is first approved therapy for hyperphagia in PWS; for ages 4+.
Approval based on Phase 3 randomized withdrawal study with mean of 3.3 years prior treatment.
Most common adverse reactions (≥10% and ≥2% over placebo): hypertrichosis, edema, hyperglycemia, rash.
Soleno expects VYKAT XR to be available in the U.S. starting April 2025.
Company launched Soleno One patient support program; conference call/webcast at 5:30 p.m. ET today.

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