Harmony Biosciences Reports Strong 2025 Financial Results and Reiterates 2026 Net Revenue Guidance of Over $1 Billion

WAKIX 2025 Net Revenue of $868.5 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy

Published on Feb. 25, 2026

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Harmony Biosciences Holdings, Inc. today announced earnings with reported revenue of $243.8 million for Q4 2025, representing 21% year-over-year revenue growth for WAKIX®. For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength as evidenced by six consecutive years of revenue growth and profitability. The company enters the year with significant momentum, reinforcing its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.

Why it matters

WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026, reflecting the strength and durability of the pitolisant franchise. The next-generation formulations of pitolisant are designed to grow Harmony's leadership in sleep-wake, extend the lifecycle of pitolisant into the 2040's, expand into additional orphan/rare indications, and now broaden the reach beyond orphan/rare into larger CNS patient populations. Harmony's robust late-stage pipeline, including five ongoing Phase 3 registrational trials across five distinct CNS indications, positions the company for multiple near-term catalysts and meaningful long-term value creation.

The details

WAKIX net product revenue for the quarter ended December 31, 2025, was $243.8 million, compared to $201.3 million for the same period in 2024. For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength. Harmony's pipeline includes the pitolisant franchise, with WAKIX on track to achieve blockbuster status in narcolepsy in 2026, as well as pitolisant in Prader-Willi syndrome, pitolisant GR, pitolisant HD, and a potential expansion into broader CNS indications. The company also has an orexin-2 receptor agonist (BP1.15205) in Phase 1 and EPX-100 (clemizole hydrochloride) in Phase 3 registrational trials for Dravet syndrome and Lennox-Gastaut syndrome.

  • WAKIX received FDA approval of the pediatric cataplexy indication on February 13th
  • Pitolisant in Prader-Willi syndrome (PWS) Phase 3 topline data readout in 2H 2026
  • Pitolisant GR NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027
  • Pitolisant HD Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2); Topline data in 2027; anticipated PDUFA date in 2028
  • Orexin-2 receptor agonist (BP1.15205) Phase 1 clinical study ongoing; anticipates clinical PK data in mid-2026

The players

Harmony Biosciences Holdings, Inc.

A pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs.

WAKIX

A first-in-class medication approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.

Pitolisant

The active ingredient in WAKIX, which is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. Harmony has an exclusive license from Bioprojet (France) to develop, manufacture and commercialize pitolisant in the United States.

Jeffrey M. Dayno, M.D.

President and Chief Executive Officer of Harmony Biosciences.

EPX-100 (clemizole hydrochloride)

A drug candidate under development by Harmony Biosciences for the treatment of Dravet syndrome and Lennox-Gastaut syndrome.

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What they’re saying

“WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026, reflecting the strength and durability of the pitolisant franchise. Based on this commercial success and our strong momentum, we see even greater opportunity for pitolisant going forward.”

— Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences (Business Wire)

What’s next

The judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

Harmony Biosciences has demonstrated the ability to successfully commercialize WAKIX and grow its pitolisant franchise, positioning the company as a profitable, self-funding biotech with a robust late-stage pipeline and strong long-term growth potential in the rare neurological disease space.