FDA Approves WAKIX for Cataplexy in Pediatric Narcolepsy

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Harmony Biosciences Holdings, Inc.

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Harmony Biosciences Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application for WAKIX (pitolisant) tablets for the treatment of cataplexy in pediatric patients aged 6 years and older with narcolepsy. WAKIX is now the first FDA-approved non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202602170805BIZWIRE_USPR_____20260217_BW839280) on February 17, 2026, and is solely responsible for the information contained therein.

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