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Jun 17, 2026
The FDA has approved WAKIX for cataplexy in pediatric narcolepsy patients, making it the first non-scheduled treatment for all ages. Harmony Biosciences reported 2025 WAKIX revenue of $868.5 million and projects 2026 sales over $1 billion, nearing blockbuster status.
Feb 25, 2026
The FDA approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 17, 2026
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
