# Harmony Biosciences Reports Record Q2 2026 WAKIX Revenue, FDA Accepts Pitolisant GR NDA, and Announces CFO Transition

> news · REPORTED · 2026-08-04

Harmony Biosciences reported record Q2 2026 net revenue for WAKIX of $261.3 million, up 30% year-over-year, reaffirmed full-year 2026 guidance of $1.0–$1.04 billion, announced FDA acceptance of the Pitolisant GR NDA with an April 1, 2027 PDUFA date, and released initial Phase 1 data for its orexin-2 agonist BP-205 while also announcing a CFO transition. The company also plans to start Phase 2 trials for BP-205 in mid-2027 and guided to Phase 3 topline data for Pitolisant HD in 2027.

About Harmony Biosciences Holdings, Inc.: Harmony Biosciences is a Nasdaq-listed pharmaceutical company that develops and commercializes therapies for rare neurological diseases, with its flagship product WAKIX (pitolisant) approved for narcolepsy-related cataplexy in adults.

- Company: Harmony Biosciences Holdings, Inc.
- Sector: therapeutics
- Primary source: https://ir.harmonybiosciences.com/news-releases/news-release-details/harmony-biosciences-preannounces-record-quarterly-revenue-q2

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