PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) said preliminary, unaudited net product revenue for its lead narcolepsy drug WAKIX reached approximately $868 million in 2025, setting the stage for blockbuster status as the company projects 2026 revenue between $1.0 billion and $1.04 billion.
The company reported fourth-quarter 2025 net product revenue of about $243 million, up from $201.3 million a year earlier, marking continued momentum for WAKIX and extending Harmony’s streak of six consecutive years of revenue growth.
Harmony said average treated patients increased by roughly 400 during the quarter to about 8,500, representing the third straight quarter of 400 or more net patient additions. Full-year 2025 revenue rose about 21 percent from $714.7 million in 2024.
“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 Dr. Jeffrey M. Dayno, the company’s president and chief executive officer. He said the company’s commercial performance, late-stage pipeline, and balance sheet position it to support long-term growth as a profitable, self-funding biotechnology company.
Harmony is advancing a broad strategy to extend the pitolisant franchise well into the 2040s through new formulations and expanded indications. A gastro-resistant version of pitolisant is on track for a new drug application submission in the second quarter of 2026, with a potential regulatory decision anticipated in the first quarter of 2027. The company said the formulation is designed to address gastrointestinal symptoms experienced by many narcolepsy patients and to allow initiation at a therapeutic dose without titration.
High-dose pitolisant programs are also advancing, with Phase 3 registrational trials ongoing in narcolepsy and idiopathic hypersomnia. Topline data are expected in 2027, with a potential regulatory filing in 2028.
Beyond pitolisant, Harmony said a Phase 1 trial is underway for BP1.15205, a next-generation orexin-2 receptor agonist, with clinical pharmacokinetic data expected in mid-2026. The company described the candidate as a potential best-in-class therapy based on preclinical potency, selectivity, and the potential for once-daily dosing.
Harmony also continues late-stage development of EPX-100, with Phase 3 registrational trials ongoing in Dravet syndrome and Lennox-Gastaut syndrome and topline data anticipated in the first half of 2027.
The company said it is phasing out development of ZYN002 following a review of data from the RECONNECT study and will no longer pursue indications in Fragile X syndrome or 22q deletion syndrome.
Harmony said it remains focused on executing its late-stage pipeline while expanding its commercial portfolio to support sustained growth and long-term value creation.