Harmony Biosciences reported a 37% increase in net revenue in the third quarter of 2023, largely attributed to the growth in patient use of its narcolepsy drug Wakix (pitolisant).

The average number of patients on Wakix increased by approximately 350 sequentially to around 5,800 for third quarter.

“We continue to demonstrate very strong growth in our commercial business, with Wakix in narcolepsy delivering the strongest revenue quarter in Harmony’s history,” says Jeffrey M. Dayno, MD, president and CEO of Harmony, in a release. “In addition, we advanced our pitolisant pipeline programs, and expanded our pipeline with the addition of Zygel through the closing of the Zynerba acquisition.”

The 37% growth versus the same period in 2022 is primarily attributed to strong commercial sales of Wakix driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the United States). 

Other company updates for the quarter:

  • Reported topline results from the Phase 3 INTUNE study in adult patients with idiopathic hypersomnia (IH). While the primary endpoint did not reach statistical significance during the randomized withdrawal phase, a robust clinical effect was demonstrated in the open label phase of the study. Based on the totality of the data, the company remains committed and continues to pursue an indication for pitolisant in IH. Next step is to meet with the FDA informed by the review of the full data set.  
  • Received FDA alignment on the protocol for the phase 3 TEMPO study in patients with Prader-Willi syndrome (PWS) which will satisfy the requirements for both the registrational trial and now pediatric exclusivity as well. We expect to initiate the study in the first quarter of 2024.   
  • On track to submit a supplemental new drug application for a pediatric narcolepsy indication to the US Food and Drug Administration in the fourth quarter of 2023.
  • Advancing new pitolisant-based formulations into the clinic in the fourth quarter of 2023. Anticipate data in the first half of 2024.