Harmony Biosciences Holdings, Inc. (HRMY) reported a 17% year-over-year increase in net product revenues for the first quarter of 2026, totaling $215.4 million, primarily driven by its commercial product Wakix. The company maintains a full-year revenue guidance of $1.0-$1.04 billion for Wakix. As of the end of the first quarter, approximately 8,600 patients were on therapy, highlighting potential for expansion given the estimated 80,000 diagnosed narcolepsy patients in the U.S.
Harmony is advancing its pipeline with plans to submit a New Drug Application for a new gastro-resistant formulation of pitolisant (Pitolisant GR) in the second quarter of 2026, targeting a potential action date in early 2027. Additionally, it is conducting global Phase III trials for EPX-100 in rare epilepsies and has a broader CNS pipeline including the orexin-2 receptor agonist BP1.15205, with pharmacokinetic data expected by mid-2026.
However, Harmony faces risks related to revenue concentration with Wakix and increasing competition in the sleep-wake market. The company has settled with six out of seven abbreviated new drug application filers, but concerns remain regarding potential generic competition which could impact future growth.
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