The Magazine for Sleep Professionals
Friday, March 20, 2026
Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult […]
Harmony Biosciences, has announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, […]
EnsoData Raises $20M to Accelerate Commercialization of AI-powered Sleep Solutions EnsoData, an innovator in AI healthtech solutions, announced a $20 million Series B financing led by Questa Capital. This new capital will enable EnsoData to accelerate adoption of its AI-powered sleep medicine solutions, improving the sleep care pathway for, in […]
Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]
Harmony Biosciences Holdings, Inc. announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH). Harmony’s 2025 net revenue guidance of $820-$860 million remains unchanged. “We […]
Harmony Biosciences Holdings, Inc. has announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R agonists […]
Harmony Biosciences Holdings, Inc. announced the presentation of new secondary endpoint data, including improvements in behavioral disturbances, from its Phase 2 signal-detection study evaluating pitolisant for the treatment of excessive daytime sleepiness (EDS) in Prader-Willi syndrome (PWS) at the 2023 Foundation for Prader-Willi Research (FPWR) Symposium and Family Conference. The […]
Harmony Biosciences Holdings, Inc. announced the FDA has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled […]
Harmony Biosciences, LLC (Harmony) announced yesterday that FDA approved WAKIX®(pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA). […]
Platform presentation highlights open-label, long-term safety and tolerability results, durability of effect over time in both EDS and cataplexy in patients with narcolepsy Harmony Biosciences, LLC (Harmony) recently presented new data on pitolisant at the 7th International Symposium on Narcolepsy in Beverly, MA. Pitolisant is an investigational product that has […]
