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FDA Grants Fast Track Designation to Investigational Narcolepsy Treatment

The oral orexin 2 receptor agonist currently in phase 1b development for patients with narcolepsy.

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New Pivotal Study Data Released for Takeda’s Oveporexton

New phase 3 data indicate that Takeda’s investigational orexin agonist, oveporexton, significantly improves daily functioning, cognition, and nighttime sleep in patients with narcolepsy type 1.

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‘Conclusive Evidence That Narcolepsy Type 1 Is a Result of the Body’s Own Immune System’

Samples from deceased brain donors reveal specific T-cells that can target orexin/hypocretin-expressing cells.

Harmony Biosciences’ Four Key Pillars to Drive Value Creation

May 14, 2026 | Emerging Compounds, Prescription Drugs

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.

Narcolepsy Network Appoints New Executive Director

May 3, 2026 | Academies & Associations, Idiopathic Hypersomnia, Narcolepsy

She brings over 20 years of nonprofit leadership and personal rare disease experience to guide the patient advocacy group.

Measuring What Matters Most to Patients With Hypersomnolence

Apr 30, 2026 | Hypersomnias

A new expert consensus identifies patient-reported outcome measures to guide research—and finds that the most debilitating symptom still lacks an adequate tool.

Alkermes to Present Sustained Efficacy Data for Alixorexton in Narcolepsy Type 1

Apr 20, 2026 | Emerging Compounds

Phase 2 Vibrance-1 study extension shows sustained improvements in patient-reported disease severity, cognitive functioning, and fatigue.

The Cognitive Toll of Narcolepsy Type 1

Apr 16, 2026 | Narcolepsy

Cognitive symptoms have largely been absent from narcolepsy clinical trials. New research defines these symptoms and illustrates their impact, with researchers hoping they will be included moving forward.

Alkermes Starts Phase 3 Program for Narcolepsy Drug Candidate Alixorexton

Apr 3, 2026 | Emerging Compounds, Hypersomnias

It will analyze once-daily and split-dose regimens of the oral orexin 2 receptor agonist in people with narcolepsy type 1 and type 2.

Eisai Begins Enrolling Phase 2 Study for Narcolepsy Treatment E2086

Mar 30, 2026 | Emerging Compounds

The dose escalation study will evaluate the efficacy, safety, and tolerability of a novel selective orexin-2 receptor agonist in adults with narcolepsy type 1 and type 2.

Why an Efficacious Drug Therapy for Narcolepsy Is Underused

Mar 21, 2026 | Hypersomnias, Prescription Drugs

Low prescribing rates persist even as evidence supports benefit, pointing to missed conversations, unclear expectations, and fragile early treatment periods.

Jazz Pharmaceuticals Reports Record 2025 Revenue, Driven by Xywav Growth

Mar 2, 2026 | Prescription Drugs

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.

Japan Grants Orphan Drug Designation to Eisai’s Novel Orexin Agonist for Narcolepsy

Feb 18, 2026 | Emerging Compounds

E2086, a selective orexin 2 receptor agonist, aims to address the pathophysiology of narcolepsy by activating orexinergic neurons.

Alkermes Completes Acquisition of Avadel Pharmaceuticals, Adding LUMRYZ to Portfolio

Feb 13, 2026 | Narcolepsy, Prescription Drugs

The acquisition accelerates Alkermes’ entry into the sleep medicine market and incorporates the FDA-approved extended-release sodium oxybate treatment for narcolepsy.

FDA Grants Priority Review to Takeda’s Oveporexton for Narcolepsy Type 1

Feb 11, 2026 | Emerging Compounds

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.

Amneal Receives FDA Approval for Sodium Oxybate Oral Solution

Feb 9, 2026 | Prescription Drugs

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.