Harmony Biosciences Gets FDA Approval for Cataplexy Treatment for Children With Narcolepsy

By Elias Schisgall

Harmony Biosciences said it received Food and Drug Administration approval for its cataplexy treatment for pediatric patients.

The company said Tuesday that the FDA greenlit a supplemental new drug application for Wakix, a treatment for cataplexy, a narcolepsy symptom characterized by sudden muscle weakness, in pediatric patients six years of age and older.

Wakix, or pitolisant, had previously been approved for adults with or without cataplexy, and for pediatric patients without cataplexy.

"Wakix is now the first-and-only FDA-approved treatment option for both pediatric and adult narcolepsy patients with or without cataplexy that is not scheduled as a controlled substance, an important distinction that supports its clinical utility," Chief Executive Officer Jeffrey Dayno said. He added that the company continues to pursue pediatric exclusivity for the treatment.

"Our sights are now set on further growing, extending and expanding the value of pitolisant through additional indications with our next-generation formulations, which have utility patents filed out to 2044," Dayno said.

Shares of Harmony were up 3.9% to $37.42 in Tuesday afternoon trading.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

February 17, 2026 15:32 ET (20:32 GMT)