Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) reported its financial results for the third quarter of 2026, revealing earnings of $0.81 per share. This marks a decrease from $0.87 per share in the same period last year and falls short of the Zacks Consensus Estimate of $1.00 per share. The decline in earnings was largely attributed to increased research and development expenses, which impacted the company’s bottom line.
Despite the earnings miss, Harmony’s quarterly revenues rose by 12% year-over-year to $269 million, although this figure slightly missed the Zacks Consensus Estimate of $271 million. The revenue growth was primarily driven by continued demand for Wakix (pitolisant), Harmony’s leading drug. The estimated average patient count for Wakix increased by 400 sequentially, reaching approximately 9,350 patients.
Year-to-date, shares of Harmony Biosciences have declined by 8.1%, contrasting with the broader industry’s gain of 11.9% over the same period1.
Analysis of Q3 Costs
Harmony Biosciences saw its total operating expenses rise by 17.5% compared to the previous year, reaching $134 million. This increase was mainly driven by a $25-million milestone payment related to MSN Labs, alongside ongoing investments in research and development and the expansion of field-based commercial teams. Consequently, net income fell to $48 million from $51 million in the same quarter of the previous year, affected by higher milestone charges and new royalty expenses associated with MSN2.
As of September 30, 2026, Harmony reported having cash, cash equivalents, and investments totaling $1,051.6 million.
Advancements in BP-205 Development
Harmony Biosciences announced promising preliminary results from a phase I study of BP-205, its investigational orexin-2 receptor agonist intended for treating narcolepsy and other central nervous system disorders. The 14-day study evaluated once-daily doses ranging from 0.1 mg to 3 mg in 94 healthy volunteers. BP-205 showed a mean time to maximum plasma concentration of about 60 minutes and an effective half-life of around 29 hours, indicating potential for rapid onset and once-daily dosing.
The drug was generally well tolerated, with no serious or severe treatment-emergent adverse events reported. Headaches were experienced by approximately 25% of participants, while insomnia and urinary-related adverse events were noted in fewer than 20%.
Harmony has initiated a study in sleep-deprived healthy volunteers, with top-line results expected in the first quarter of 2027. Phase II studies across multiple CNS indications are planned for mid-20273.
Progress in Pitolisant and Epilepsy Programs
The U.S. Food and Drug Administration (FDA) is currently reviewing the new drug application for pitolisant gastro-resistant (GR), with a target action date of April 1, 2027. Harmony anticipates launching the GR formulation in the first half of 2027, pending regulatory approval.
Harmony continues to advance pitolisant HD through phase III ONSTRIDE 1 and ONSTRIDE 2 studies, targeting narcolepsy and idiopathic hypersomnia, respectively. Top-line results are expected in 2027, with potential regulatory action anticipated in 2028.
Additionally, the company’s phase III TEMPO study of Wakix in Prader-Willi syndrome is actively recruiting, with top-line data expected in mid-2027. The EPX-100 program is progressing through phase III LIGHTHOUSE and ARGUS studies targeting Lennox-Gastaut syndrome and Dravet syndrome, respectively, with results anticipated in mid-2027 and potential regulatory action targeted for 2028.
Revenue Outlook and Strategic Focus
Harmony Biosciences reaffirmed its full-year 2026 revenue guidance for Wakix, projecting net revenues between $1 billion and $1.04 billion. The company remains on track to achieve its first-ever $1 billion annual revenue milestone, driven by sustained patient demand, expanded commercial infrastructure, and improved reimbursement support.
Despite the expected introduction of Takeda’s competing narcolepsy treatment, Orzeyful, Harmony is confident in Wakix’s unique position as the only nonscheduled treatment option for narcolepsy.
Harmony is also focusing on patent protection for Wakix, having settled with six of the seven abbreviated new drug application filers. The company expects to maintain exclusivity through March 2030, including anticipated pediatric exclusivity. A preliminary injunction hearing involving AET Pharma and Sandoz is scheduled for January 26, 2027, ahead of the February 2027 expiration of the regulatory stay.
In leadership news, Peter Anastasiou will succeed Jeffrey Dayno as president and CEO effective January 1, 2027.
Footnotes:
- Harmony Biosciences’ stock performance contrasts with the broader industry’s gains. Source.
- The increase in operating expenses was driven by milestone charges and royalty expenses. Source.
- BP-205’s development shows potential for rapid onset and once-daily dosing. Source.
Featured Image: Megapixl @ 123dartist
