FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “Harmony Biosciences Holdings, Inc. is Set To Initiate Phase 3 Clinical Trial For Treatment Of Idiopathic Hypersomnia”
Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) climbed over 5% in premarket trading after the FDA accepted an Investigational New Drug application for pitolisant for the treatment of idiopathic hypersomnia.
Harmony is now planning to initiate a Phase 3 clinical trial to evaluate the safety and efficacy of pitolisant in adult patients with IH in the first half of 2022.
Idiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be alleviated by naps, longer sleep or more efficient sleep. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and ‘brain fog’ (impaired cognition, attention, and alertness). The cause of IH is unknown, but it is likely due to alterations in areas of the brain that stabilize states of sleep and wakefulness. IH is one of the central disorders of hypersomnolence and, like narcolepsy, is a debilitating sleep disorder that can result in significant disruption in daily functioning.
For more information, please visit: Harmoney Biosciences Holdings, Inc.
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