Harmony Biosciences gains expanded FDA approval for Wakix

Shares of Harmony Biosciences (Nasdaq: HRMY) were up more than 6% at $37.24 mid-morning today, after it announced that the US Food and Drug Administration has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy.

Wakix is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the US Drug Enforcement Administration.

Wakix, which was licensed for the US market from France-based Bioprojet in 2017, received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. Its main competitor in the US market is Xyrem (sodium oxybate), developed by Ireland-headquartered Jazz Pharmaceuticals (Nasdaq: JAZZ), and which pulled in sales of $854.7 million in the first half of 2020.