WAKIX Revenue to Exceed $1B in 2026, Orexin-2 Receptor Agonist in Pipeline

Harmony Biosciences, has announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential. Harmony highlighted its commercial performance and pipeline advancements at its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 4:30 p.m. PT / 7:30 p.m. ET in San Francisco, CA.

“With WAKIX on track to achieve revenue of over $1 billion in narcolepsy in 2026, Harmony is entering its next phase of growth with significant momentum,” said Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences. “Our proven commercial engine is driving exceptional performance with WAKIX, our next-gen formulations are positioned to extend and expand the pitolisant franchise well into the 2040s, and we continue to advance our late-stage pipeline with five ongoing Phase 3 registrational trials toward five distinct CNS indications. As a profitable, self-funding biotech with a strong balance sheet, we are well-positioned to build out our pipeline and expand our commercial portfolio to drive long-term value creation.”

Fourth Quarter and Full Year 2025 Net Product Revenue for WAKIX (Preliminary and Unaudited)

• Preliminary, unaudited net product revenue for the quarter ended December 31, 2025, was approximately $243 million, compared to $201.3 million for the same period in 2024
• Increase of ~400 patients to achieve ~8,500 average number of patients in Q4 2025; representing the third consecutive quarter of ~400+ patient adds
• Preliminary, unaudited net product revenue for the full year ended December 31, 2025, was approximately $868 million, compared to $714.7 million for the full year ended December 31, 2024, representing ~21% growth year on year

Pitolisant Franchise Strategy

• WAKIX: On track to achieve blockbuster status in narcolepsy
  • Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026
  • Pitolisant in Prader-Willi syndrome (PWS)
    • Phase 3 topline data readout in 2H 2026
    • Supports Pediatric Exclusivity for WAKIX: Fulfills the last regulatory requirement for six months of additional regulatory exclusivity on top of the longest patent for WAKIX
• Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s
  • NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027
    • Approximately 80-90% of patients with narcolepsy experience GI symptoms; pitolisant GR is designed to minimize the worsening of these symptoms
    • Ability to initiate treatment at therapeutic dose with no titration
  • Utility patents filed to extend franchise to the 2040s
• Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated indications
  • Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2)
    • Topline data in 2027; anticipated PDUFA date in 2028
    • Enhanced formulation with optimized PK profile, GR coating and higher dose to drive greater efficacy
    • Differentiated indications: fatigue in narcolepsy and sleep inertia in IH
  • Utility patents filed to expand franchise to the 2040s

Robust Pipeline

• Orexin-2 receptor agonist (BP1.15205)
  • First subject dosed in Phase 1 PK trial in Q4 2025
  • Phase 1 clinical PK data in mid-2026
  • Potential best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity, safety and efficacy data, and potential for once-a-day dosing
• EPX-100 (clemizole hydrochloride)
  • One of the most advanced development programs in the 5HT2 (serotonin) agonist class
  • Enrollment ongoing for Phase 3 registrational trial in Dravet syndrome (ARGUS Study) with topline data anticipated in 1H 2027
    • Safety and effectiveness data from the open-label extension study in DS was presented at AES meeting in December 2025
  • Enrollment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 1H 2027

ZYN002 Update

• After an in-depth review of the data from the RECONNECT study, the ZYN002 program in Fragile X syndrome is being phased out and Harmony is no longer pursuing a 22q deletion syndrome indication.

Source: Harmony BioSciences