The Magazine for Sleep Professionals
Monday, April 6, 2026
Alkermes plc, announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development […]
Eisai Inc. announced today that screening for global Study E2086-G000-202 (Study 202) to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on ClinicalTrials.gov as NCT07493265. Study sites are also planned for Canada, China, Europe, Japan, and South Korea. Study 202 is a three-period, […]
Eli Lilly and Company and Centessa Pharmaceuticals plc, a clinical-stage company developing a new class of medicines for the treatment of excessive daytime sleepiness and other neurological conditions, announced a definitive agreement for Lilly to acquire Centessa. Centessa is advancing a pipeline of orexin receptor 2 (OX2R) agonists designed to […]
Narcolepsy is a chronic condition in which someone feels excessively sleepy, occasionally falling asleep without warning. This can have a major impact on their daily lives, affecting not only their education and employment, but also their ability to drive, their relationships, and their emotional health. “It’s quite striking when you’re […]
LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]
Nexalin Technology, Inc. announced continued advancement toward its planned pivotal clinical trial evaluating HALO™ Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin’s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical […]
REMSleep Holdings, Inc., developer of the FDA-cleared DeltaWave(TM) nasal pillow system, announced the full commercial launch of the DeltaWave product portfolio across all U.S. distribution channels, including durable medical equipment (DME) companies and institutional sales. With expanded FDA 510(k) clearance secured on January 15 and Medicare PDAC coding approved for every product […]
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 […]
Sunrise Group, a pioneer in medical device innovation and sleep care, today announced a new peer-reviewed study in Nature Communications Medicine. Sunrise developed the only home sleep test with respiratory effort measurement that has been validated against esophageal pressure, the reference standard. The study reveals that REMOV, the Sunrise-specific marker […]
