Harmony Biosciences (HRMY) Announces FDA Grants Priority Review for Application For Wakix (Pitolisant) In Pediatric Narcolepsy

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Go back to Harmony Biosciences (HRMY) Announces FDA Grants Priority Review for Application For Wakix (Pitolisant) In Pediatric Narcolepsy

U.S. FOOD AND DRUG ADMINISTRATION GRANTS PRIORITY REVIEW TO HARMONY BIOSCIENCES' APPLICATION FOR WAKIX® (PITOLISANT) IN PEDIATRIC NARCOLEPSY

February 21, 2024 8:05 AM EST

Prescription Drug User Fee Act date is June 21, 2024

PLYMOUTH MEETING, Pa., Feb. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) granted priority review for its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age and older with narcolepsy. The FDA has set a Prescription Drug User Fee Act... More