By Colin Kellaher
Harmony Biosciences Holdings said the Food and Drug Administration has turned away its application seeking expanded approval of its Wakix narcolepsy drug for the treatment of excessive daytime sleepiness in adults with the chronic sleep disorder idiopathic hypersomnia.
Harmony on Wednesday said the FDA issued a "refusal-to-file" letter, which indicates that an application is incomplete and won't be reviewed.
Harmony last year filed for the expanded approval of pitolisant, as Wakix is known generically, despite the drug missing its primary endpoint in a Phase 3 study in patients with idiopathic hypersomnia.
The Plymouth Meeting, Pa., company termed the FDA's refusal to file a short-term setback and said its long-term strategy for pitolisant in idiopathic hypersomnia is on track with its focus on a higher-dose formulation of the drug.
Harmony said it expects to launch a Phase 3 registrational study of pitolisant HD in the fourth quarter, with a target of FDA approval in idiopathic hypersomnia in 2028.
The company noted that the setback doesn't change its 2025 revenue guidance of $820 million to $860 million.
Harmony shares were recently down 8.1% to $35.93 in early trading Wednesday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 19, 2025 09:55 ET (14:55 GMT)
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