Many more people work very early morning shifts than overnight ones, and a large proportion struggle with excessive sleepiness from shift work disorder, leading to problems with focus, performance and safety. A new clinical trial by investigators from Mass General Brigham found that the wake-promoting drug solriamfetol (Sunosi) helped early […]
Sleep Pharmaceuticals
Apnimed Secures $150M to Advance AD109 Toward Launch
Apnimed, Inc., announced that it has entered into a senior secured credit facility for up to $150 million with funds managed by HealthCare Royalty Partners (“HCRx”). The capital is expected to support commercial readiness activities and the planned U.S. launch of Apnimed’s lead product candidate, AD109, if approved by the […]
Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2
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 […]
Lilly to Acquire Centessa to Advance Treatments for Sleep-Wake Disorders
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 […]
Harmony Biosciences Receives FDA Approval for WAKIX for the Treatment of Cataplexy in Pediatric Narcolepsy
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 Completes Acquisition of Avadel, Accelerating Entry Into Sleep Medicine Market
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 […]
U.S. FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
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 […]
WAKIX Revenue to Exceed $1B in 2026, Orexin-2 Receptor Agonist in Pipeline
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, […]
QUVIVIQ Wins Best Biotechnology & Pharmaceutical Product
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. […]
A New Piece of the Puzzle
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 […]













