Harmony Biosciences Holdings (HRMY) said Monday that its supplemental new drug application for WAKIX tablets to treat excessive daytime sleepiness in narcolepsy pediatric patients aged 6 years and older has been approved by the US Food and Drug Administration.
The approval follows a phase 3 study demonstrating safety and efficacy of pitolisant in patients aged 6 years to under 18 years, the company said.
Shares of the company were up 2.8% in Monday premarket activity.
Price: 30.98, Change: +0.85, Percent Change: +2.82
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