Key Takeaways:
Harmony Biosciences Holdings Inc. reported preliminary second-quarter net product revenue of approximately $261 million for WAKIX (pitolisant), a record quarterly figure that beat the prior quarter by 21% and marked 30% growth from a year earlier.
"The results reflect the continued strength of the WAKIX franchise and sustained momentum across the business," Jeffrey M. Dayno, president and chief executive officer at Harmony Biosciences, said. "Demand remains strong, our commercial execution continues to deliver results and, based on our performance through the first half of the year, we remain confident in our ability to achieve full-year net revenue of $1 billion to $1.04 billion."
The company reaffirmed its full-year 2026 net product revenue guidance of $1 billion to $1.04 billion, citing first-half performance and current business trends. Harmony will report complete second-quarter financial results and provide a business update on Aug. 4.
Harmony also announced that Chief Financial Officer Glenn Reicin stepped down effective July 16 to pursue other opportunities. The company appointed Stephen Mollichella, senior vice president and controller, as interim principal financial officer while it conducts a search for a permanent CFO. Mollichella joined Harmony in 2021 and has led financial accounting, reporting, systems and controls. Harmony said Reicin's departure was not the result of any disagreement on matters relating to operations, policies or practices and does not expect the transition to affect performance.
WAKIX Franchise Expansion
WAKIX, approved by the FDA in August 2019 for excessive daytime sleepiness in adults with narcolepsy and expanded to cataplexy in adults in October 2020, has extended into the pediatric market. The FDA approved WAKIX for pediatric EDS in 2024 and for cataplexy in patients six years and older in February 2026, providing additional growth avenues.
Harmony is pursuing label expansion beyond narcolepsy into rare neurological disorders. The company is conducting the Phase III TEMPO study in Prader-Willi syndrome, supported by FDA alignment, with potential to serve as a registrational trial. The FDA granted orphan drug designation to pitolisant for PWS in 2024. In myotonic dystrophy type 1, Phase II data showed meaningful improvements in EDS and fatigue.
The company is also advancing two next-generation pitolisant formulations. Harmony plans to submit a new drug application for pitolisant GR (gastro-resistant), designed with an enteric coating to reduce gastrointestinal side effects and allow dosing without titration. An FDA decision is expected in the first quarter of 2027. Utility patents have been filed that could extend franchise protection into the 2040s. Pitolisant HD (high dose) is in Phase III studies for narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2), with top-line data expected in 2027.
Shares of Harmony traded more than 5% lower on the day of the announcement, paring early losses after hitting the 200-day moving average. The stock has lost about 11% year to date.
The record revenue signals that WAKIX demand remains on an accelerating trajectory, with the first half of 2026 already generating enough momentum to support the upper half of the full-year guidance range. Investors will watch the Aug. 4 earnings call for updated segment details and pipeline timelines.
This article is for informational purposes only and does not constitute investment advice.
