Plymouth Meeting’s Harmony Biosciences’ stock fell 10% on Wednesday after the FDA rejected the expansion of its insomnia drug, Wakix, writes John George for the Philadelphia Business Journal.
Wakix, containing the active ingredient pitolisant, is currently approved for managing excessive daytime sleepiness and cataplexy in narcolepsy patients. Idiopathic hypersomnia is a chronic condition causing excessive daytime sleepiness despite adequate nighttime rest. It affects approximately 1 in 50,000 people in the U.S.
CEO Dr. Jeffrey Dayno expressed disappointment over the FDA’s decision but reaffirmed the company’s commitment to addressing idiopathic hypersomnia. Harmony Biosciences anticipated the rejection. Late-stage clinical trials showed that Wakix did not meet its primary endpoint of overall improvement in excessive daytime sleepiness. However, the drug did demonstrate significant results in reducing disease severity and enhancing functional status.
In response, Harmony plans to shift focus to developing Pitolisant HD, an advanced, higher-dose formulation of Wakix.
Despite this setback, Wakix generated $714 million in sales last year, a 23% increase from $582 million in 2023. Harmony, now with 274 employees, projects Wakix’s sales to reach between $820 million and $860 million this year. The company’s development pipeline also includes treatments for narcolepsy, Fragile X syndrome, Dravet syndrome, and Lennox-Gastaut syndrome.
Read more about Harmony Biosciences in the Philadelphia Business Journal.
