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: WAKIX
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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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WAKIX Time-to-Onset & Cardiovascular Safety Data Presented at AAN 2021
"These analyses further characterize the efficacy and safety profile of WAKIX and its broad clinical utility for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy."
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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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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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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Wakix Patent Challenge Rejected by US Patent Office
The United States Patent and Trademark Office has denied a Petition for Reexamination concerning a patent covering the active ingredient in Wakix (pitolisant).
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Wakix Hits Record High Prescription Demand in Q2
Harmony Biosciences reported second-quarter business updates, showcasing an upswing in prescription demand for its narcolepsy drug, Wakix.
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Harmony to Begin Phase 3 Study of Pitolisant for Prader-Willi Syndrome
The study will further investigate pitolisant in children, adolescents, and adults with Prader-Willi syndrome experiencing excessive daytime sleepiness.
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Pitolisant Receives Approval in China for Narcolepsy Treatment
The approval makes pitolisant the first and only treatment drug approved in mainland China for narcolepsy.
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Harmony Announces Positive Phase 2 Data on Pitolisant for Prader-Willi Syndrome
Harmony Biosciences presented safety and efficacy data from a phase 2 study evaluating pitolisant for the treatment of excessive daytime sleepiness in people with Prader-Willi syndrome at SLEEP 2023.
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Harmony Hits Enrollment Target Early for Phase 3 Study of Pitolisant for IH
The phase 3 registrational INTUNE study will evaluate the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia.
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Harmony to Present Phase 2 Results of Pitolisant in Prader-Willi Syndrome
Harmony Biosciences will present the results, which it says it is “especially encouraged by,” during a poster presentation at SLEEP 2023 in Indianapolis.
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Harmony Biosciences Reports Continued Momentum for Pitolisant
The company reported business updates for the quarter ending March 31, noting continued momentum in its commercial business for Wakix, as well as in the advancement of its clinical development programs for pitolisant for the treatment of idiopathic hypersomnia.
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Harmony Biosciences Appoints New CEO
The new CEO joined Harmony Biosciences as chief medical officer and executive vice president when the company was founded in 2017 and has been serving as interim president and CEO since Jan. 6.
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Pitolisant Trial for Idiopathic Hypersomnia Ahead of Schedule
Harmony Biosciences announced an accelerated timeline for completing its phase 3 study evaluating pitolisant in adults idiopathic hypersomnia.
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Wakix Approved for Narcolepsy Treatment in Children in Europe
The European Medicines Agency approved Wakix for the treatment of narcolepsy in children over 6 years of age, with or without cataplexy.
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Harmony Biosciences Provides 2022 Business Updates
Harmony Biosciences spelled out next steps in its pursuit of pediatric exclusivity for WAKIX.
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