The Magazine for Sleep Professionals
Tuesday, March 17, 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, […]
Idorsia Ltd announces that its novel treatment for insomnia disorder QUVIVIQ (Daridorexant) has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”. The award recognizes groundbreaking medicines, including biologics, gene therapies, and traditional pharmaceutical compounds, that advance patient care through scientific innovation. […]
For the millions of people managing both obesity and obstructive sleep apnea (OSA), tirzepatide (Zepbound® and Mounjaro®, Eli Lilly and Co.) may offer a welcome approach to help reduce symptoms and improve overall health and quality of life. It’s been almost exactly a year since investigators of the SURMOUNT-OSA trial […]
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 […]
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) […]
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, and XWPharma Ltd. (“XWPharma”) together announced today that Avadel has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABAB receptor agonist, for all indications, including the treatment of sleep disorders, such […]
Millions of people worldwide who suffer with chronic insomnia are all too familiar with its profound impact on cognitive function, mood, and overall health and well-being. Many of these patients have success with first-line treatments like cognitive behavioral therapy (CBT) and pharmacological interventions, but relief remains elusive for many with […]
