Alkermes Granted Orphan Drug Designations for Alixorexton in US, Europe
The investigational oral orexin 2 receptor agonist received designations from the FDA for idiopathic hypersomnia and the European Commission for narcolepsy.
Tag: Narcolepsy
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Harmony Biosciences’ Four Key Pillars to Drive Value Creation
Harmony Biosciences reported a 17% year-over-year growth for WAKIX in the first quarter of 2026 and detailed four strategic priorities focused on long-term growth.
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FDA Approves First Non-Scheduled Drug for Cataplexy in Pediatric Narcolepsy Patients
The treatment was previously approved for excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy.
Why an Efficacious Drug Therapy for Narcolepsy Is Underused
Low prescribing rates persist even as evidence supports benefit, pointing to missed conversations, unclear expectations, and fragile early treatment periods.
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Jazz Pharmaceuticals Reports Record 2025 Revenue, Driven by Xywav Growth
The low-sodium oxybate oral solution generated $1.7 billion in revenue, contributing to the company’s $3.1 billion neuroscience portfolio performance in 2025.
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Japan Grants Orphan Drug Designation to Eisai’s Novel Orexin Agonist for Narcolepsy
E2086, a selective orexin 2 receptor agonist, aims to address the pathophysiology of narcolepsy by activating orexinergic neurons.
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Alkermes Completes Acquisition of Avadel Pharmaceuticals, Adding LUMRYZ to Portfolio
The acquisition accelerates Alkermes’ entry into the sleep medicine market and incorporates the FDA-approved extended-release sodium oxybate treatment for narcolepsy.
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FDA Grants Priority Review to Takeda’s Oveporexton for Narcolepsy Type 1
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.
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Amneal Receives FDA Approval for Sodium Oxybate Oral Solution
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.
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Harmony Biosciences Projects WAKIX Revenue to Surpass $1 Billion in 2026
The company’s narcolepsy treatment shows strong growth, while its late-stage pipeline advances with five phase 3 trials and a novel orexin agonist.
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Avadel Shareholders Approve Acquisition by Alkermes
The deal will bring the narcolepsy treatment LUMRYZ under the Alkermes portfolio.
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Axsome to Submit New Drug Application for Narcolepsy Treatment AXS-12
The upcoming submission for AXS-12 (reboxetine) for cataplexy in narcolepsy follows supportive feedback from the FDA.
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FDA Grants Alixorexton Breakthrough Therapy Designation for Narcolepsy Type 1
The designation for the investigational oral orexin 2 receptor agonist aims to expedite development based on positive phase 2 clinical trial data.
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Centessa’s Orexin Agonist ORX750 Shows Efficacy in Narcolepsy, IH Trials
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.
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Harmony Advances Pitolisant GR After Bioequivalence Success
Positive trial results position the next-generation pitolisant formulation for a New Drug Application in early 2026.
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Takeda Expands AI Partnerships to Scale Narcolepsy Care
The pharmaceutical giant deepens collaboration with Beacon Biosignals and partners with EnsoData to address challenges in narcolepsy type 1.
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Harmony Advances First Human Study of Orexin 2 Agonist
BP1.15205 enters phase 1 testing as Harmony positions the selective OX2R agonist to broaden treatment choices for narcolepsy and other hypersomnolence disorders.
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Alkermes Shares Phase 2 Results of Orexin 2 Receptor Agonist in Narcolepsy Type 2
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.
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