The brain has neuronal systems that respond to skin temperature. In narcolepsy, these systems act as a switch, determining whether the brain enters REM sleep or triggers muscle paralysis while the person is awake.
Phase 2 Vibrance-1 study extension shows sustained improvements in patient-reported disease severity, cognitive functioning, and fatigue.
The treatment was previously approved for excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy.
The acquisition accelerates Alkermes’ entry into the sleep medicine market and incorporates the FDA-approved extended-release sodium oxybate treatment for narcolepsy.
Read More
The investigational oral OX2R-selective agonist is designed to restore orexin signaling; the FDA has set a target action date for the third quarter of 2026.
Read More
The approval allows Amneal to offer a generic alternative for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy patients, expanding access to this standard of care therapy.
Read More
The company’s narcolepsy treatment shows strong growth, while its late-stage pipeline advances with five phase 3 trials and a novel orexin agonist.
Read More
The deal will bring the narcolepsy treatment LUMRYZ under the Alkermes portfolio.
Read More
The upcoming submission for AXS-12 (reboxetine) for cataplexy in narcolepsy follows supportive feedback from the FDA.
Read More
The designation for the investigational oral orexin 2 receptor agonist aims to expedite development based on positive phase 2 clinical trial data.
Read More
The company also announced a CEO transition to sharpen its focus on its orexin pipeline as phase 2a data shows ORX750 improved key measures of wakefulness and cataplexy.
Read More
Positive trial results position the next-generation pitolisant formulation for a New Drug Application in early 2026.
Read More
The pharmaceutical giant deepens collaboration with Beacon Biosignals and partners with EnsoData to address challenges in narcolepsy type 1.
Read More
BP1.15205 enters phase 1 testing as Harmony positions the selective OX2R agonist to broaden treatment choices for narcolepsy and other hypersomnolence disorders.
Read More
Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor agonist in phase 2 development for the treatment of narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
Read More
A man in his 40s sat in front of clinical psychologist Christopher Wendel, PhD, DBSM, one early afternoon on the grey couch where Wendel sees all his behavioral sleep therapy clients. “What brings you in?” Wendel asked.
Read More
Phase 4 DUET trial and real-world data presented at World Sleep 2025 and Psych Congress 2025 highlight low-sodium Xywav’s impact on sleep continuity, alertness, and cardiometabolic risk profiles in adults with narcolepsy or idiopathic hypersomnia.
Read More
The $2.1 billion all-cash deal will bring Avadel’s once-nightly oxybate, LUMRYZ, under Alkermes’ umbrella as it advances its orexin agonist pipeline for narcolepsy and other hypersomnolence disorders.
Read More