PLYMOUTH MEETING, PA — Harmony Biosciences posted another quarter of rapid expansion, driven by accelerating demand for its flagship narcolepsy therapy WAKIX® and a late-stage pipeline approaching multiple Phase 3 milestones. The company reported $239.5 million in third-quarter revenue, up 29% from a year earlier, as average patient numbers hit a record 8,100 — an increase of roughly 500 versus the prior quarter.
With more than $778 million in cash and investments on the balance sheet, Harmony reinforced its status as one of the few profitable, self-funded biotechs advancing a broad late-stage portfolio. CEO Jeffrey M. Dayno said the performance underscores WAKIX’s strong market trajectory and the company’s ability to execute at scale.
WAKIX continues to gain share in the roughly 80,000-patient U.S. narcolepsy market. The company recently raised full-year 2025 revenue guidance to a range of $845 million to $865 million, up from $820 million to $860 million.
Harmony is also advancing several pivotal programs. An Investigational New Drug application has been submitted for Pitolisant HD, a higher-dose formulation designed to offer improved efficacy with an optimized pharmacokinetic profile. Phase 3 trials in narcolepsy and idiopathic hypersomnia are set to begin in the fourth quarter, with potential FDA action targeted for 2028.
A gastro-resistant formulation, Pitolisant GR, remains on track for a key bioequivalence readout later this year. Early data suggest the formulation may allow patients to begin treatment at therapeutic doses without titration.
Harmony’s orexin-2 receptor agonist candidate, BP1.15205, is expected to enter first-in-human testing in the fourth quarter, with Phase 1 data anticipated in 2026. Preclinical findings presented at major sleep conferences suggest the compound may emerge as a best-in-class entrant.
Beyond sleep disorders, the company is pushing forward two Phase 3 epilepsy programs — EPX-100 in Dravet syndrome and Lennox-Gastaut syndrome — with topline data expected in 2026.
Net income for the quarter rose to $50.9 million, or $0.87 per diluted share, compared with $46.1 million in the prior-year period. Adjusted net income reached $63.5 million. Operating expenses rose sharply, largely due to increased R&D investment, including a $15 million milestone payment tied to progress in the ZYN002 program.
Harmony’s leadership said the company plans to strategically deploy its substantial cash resources to expand its portfolio and pursue acquisitions that complement its focus on unmet neurological and sleep-wake disorders.
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