The Magazine for Sleep Professionals
Friday, March 13, 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 […]
Alkermes plc and Avadel Pharmaceuticals plc, announced Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ®, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep […]
Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes […]
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, […]
Eisai Co., Ltd. announced today that the results from a Phase Ib clinical trial (NCT06462404) of its in-house developed novel selective orexin 2 receptor agonist E2086 have been presented at the World Sleep 2025 congress, held in Singapore from September 5 to 10. These data demonstrate that once-daily dosing of […]
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 […]
Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore. Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) […]
Attendees traveled from near and far to join us in person and online for the 2025 Wake Up Narcolepsy National Summit in Raleigh-Durham, N.C. Hosted in a different city each year, the summit provides a place where industry professionals, clinicians, individuals with narcolepsy, and family members can come together and […]
EnsoData has announced a collaboration with Takeda to jointly develop and validate AI-based polysomnography (PSG) algorithms to support more accurate and scalable diagnosis of narcolepsy type 1 (NT1). Upon successful validation and regulatory clearance, EnsoData will pursue the clinical availability and release of AI algorithms to enable future access, use, […]
Narcolepsy research is entering an exciting phase, with promising new treatments and discoveries on the horizon. Because narcolepsy symptoms can cause daily disruptions, affecting everything from work to relationships, having effective treatments makes a meaningful difference in improving quality of life. At Wake Up Narcolepsy (WUN), we’re committed to not […]
