# Harmony Biosciences Q2 2026: WAKIX on Track for Over $1 Billion Annual Revenue, Pitolisant GR NDA Accepted

> news · REPORTED · 2026-08-04

Harmony Biosciences reported on August 4, 2026 that its pitolisant granule formulation NDA was accepted by the FDA in July with a PDUFA target date of April 1, 2027, while full-year WAKIX revenue guidance of $1.0 to $1.04 billion was reaffirmed. The company also disclosed that the pitolisant HD Phase 3 is on track for topline data in 2027.

About Harmony Biosciences Holdings, Inc.: Harmony Biosciences Holdings is a rare neurological disease-focused pharmaceutical company commercializing WAKIX (pitolisant) for narcolepsy and advancing a pipeline of CNS therapies including next-generation pitolisant formulations and BP-205.

- Company: Harmony Biosciences Holdings, Inc.
- Sector: therapeutics
- Primary source: https://www.sec.gov/Archives/edgar/data/0001802665/000110465926090086/hrmy-20260804xex99d1.htm

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