# FDA Approves WAKIX for Pediatric Cataplexy in Narcolepsy; Q2 Revenue Hits Record $261M

> fda · REPORTED · 2026-08-04

Harmony Biosciences announced FDA approval of a supplemental NDA for WAKIX (pitolisant) to treat cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the first and only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. The company also reported record Q2 2026 WAKIX net revenue of $261.3 million, up 30% year-over-year, and reiterated full-year 2026 revenue guidance of $1.0 to $1.04 billion.

About Harmony Biosciences Holdings, Inc.: Harmony Biosciences is a commercial-stage pharmaceutical company focused on developing and commercializing therapies for patients with rare neurological diseases, led by its flagship product WAKIX (pitolisant) for narcolepsy.

- Company: Harmony Biosciences Holdings, Inc.
- Sector: therapeutics
- Primary source: https://ir.harmonybiosciences.com/news-releases/news-release-details/harmony-biosciences-receives-us-food-and-drug-administration-1

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.