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Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy

Harmony Biosciences (HRMY)Harmony BiosciencesFDA / regulatory

PLYMOUTH MEETING, Pa. --(BUSINESS WIRE)--Feb. 17, 2026-- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX ® (pitolisant) tablets for the treatment of cataplexy in pediatric

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Harmony Biosciences

Sleep and Neurologic Disorders Harmony Biosciences develops and commercializes medicines for rare neurologic diseases. Its business is anchored by therapies that regulate wakefulness and sleep-wake signaling. WAKIX Franchise WAKIX, or pitolisant, is a histamine H3 receptor antagonist/inverse agonist used in narcolepsy and is the...

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Stock data

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38.15 USD
Market cap
1.79B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States