# Harmony Reports Record Q2 Revenue, Releases Phase 1 BP-205 Data, and Gets FDA NDA Acceptance for Pitolisant GR

> clinical trial · REPORTED · 2026-08-04

Harmony Biosciences reported Q2 2026 WAKIX net revenue of $261.3 million, up 30% year-over-year, and released favorable Phase 1 single ascending dose data for its orexin-2 receptor agonist BP-205, supporting a potential best-in-class profile. The company also announced FDA acceptance of its Pitolisant GR NDA with an April 1, 2027 PDUFA date.

About Harmony Biosciences Holdings, Inc.: Harmony Biosciences is a pharmaceutical company focused on developing and commercializing therapies for patients with rare neurological diseases, with WAKIX (pitolisant) as its flagship FDA-approved treatment for narcolepsy.

- Company: Harmony Biosciences Holdings, Inc.
- Sector: therapeutics
- Primary source: https://www.globenewswire.com/news-release/2026/08/04/3338190/0/en/Harmony-Biosciences-Announces-Record-Q2-2026-Revenue-and-Shares-Initial-Clinical-Data-for-Its-Orexin-2-Agonist-BP-205-Reinforcing-Potential-Best-in-Class-Profile.html

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