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.
Tag: Harmony Biosciences
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The Race Toward Orexin Agonists Targeting Narcolepsy’s Root Cause
Drug candidates aim to address the root cause of narcolepsy type 1—orexin deficiency—with some also being explored for narcolepsy type 2 and idiopathic hypersomnia.
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FDA Approves Non-Scheduled Narcolepsy Drug for Children
The FDA has expanded the approval of a narcolepsy drug, previously approved for adults, to now include children aged 6 and older.
FDA Rejects Petition Challenging Safety of Narcolepsy Drug Wakix
The FDA maintains its approval for the narcolepsy treatment in adults and recently expanded use in pediatric patients.
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Pitolisant Improves Fatigue in Myotonic Dystrophy Patients
A phase 2 study presented at SLEEP 2024 found pitolisant reduced excessive daytime sleepiness and fatigue in adults with myotonic dystrophy type 1.
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Harmony’s Q1 Report Shows Strong Growth in Sleep/Wake Portfolio
First-quarter highlights include increased patient uptake of Wakix and steps toward advancing pitolisant for idiopathic hypersomnia.
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Harmony Secures Rights to Develop Bioprojet’s Orexin-2 Agonist
The orexin-2 agonist is being evaluated for the treatment of narcolepsy and other sleep/wake disorders, with the potential to offer a best-in-class clinical profile due to its potency, selectivity, and preclinical safety profile.
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Harmony Initiates Phase 3 Study of Pitolisant for Prader-Willi Syndrome
The TEMPO study will evaluate the safety and efficacy of pitolisant for treating excessive daytime sleepiness and behavioral symptoms in patients with Prader-Willi syndrome.
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FDA Grants Priority Review for Wakix in Pediatric Narcolepsy Treatment
The FDA has granted priority review to Harmony Biosciences’ supplemental New Drug Application for Wakix for treating excessive daytime sleepiness or cataplexy in children aged 6 and older with narcolepsy.
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FDA Grants Orphan Drug Designation to Pitolisant in Prader-Willi Syndrome
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Harmony...
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How to Select the Most Suitable Pharmacotherapy for Type 1 Narcolepsy Patients
Sleep specialists share practical tips on choosing medications that treat narcolepsy symptoms, including excessive daytime sleepiness and cataplexy.
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Harmony Reports Growth in Patient Use of Narcolepsy Drug Wakix
Harmony Biosciences announced an increase in the usage of its narcolepsy drug Wakix (pitolisant) during the fourth quarter.
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Pitolisant Shows Promise in Treating Sleepiness in Myotonic Dystrophy Patients
Positive topline results evaluating the safety and efficacy of pitolisant in adult patients with myotonic dystrophy type 1 showed clinically meaningful improvements in excessive daytime sleepiness and fatigue.
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Usage Up for Narcolepsy Drug Wakix in Q3, Harmony Biosciences Reports
Harmony Biosciences reported a 37% increase in net revenue in the third quarter, largely attributed to the growth in patient use of its narcolepsy drug Wakix.
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Harmony Announces Newest Patients and Progress at the Heart Award Recipients
Harmony Biosciences has chosen the newest recipients of its Patients at the Heart and Progress at the Heart awards, offering financial backing to projects tackling issues faced by those with sleep disorders and rare neurological conditions.
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Pitolisant Misses Primary Endpoint in Phase 3 Study for IH
Topline results from the INTUNE study of pitolisant for idiopathic hypersomnia revealed that the primary endpoint for excessive daytime sleepiness did not achieve statistical significance against a placebo in the randomized withdrawal phase.
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Pitolisant May Improve Behavior Disturbances, Sleepiness in Prader-Willi Syndrome
Harmony Biosciences announced new secondary endpoint data from its phase 2 signal-detection study evaluating pitolisant for the treatment of excessive daytime sleepiness in Prader-Willi syndrome.
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Harmony Gets FDA Orphan Drug Designation for Pitolisant for Idiopathic Hypersomnia
Harmony Biosciences is currently evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia in a phase 3 study, with topline results anticipated in the fourth quarter.
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