Shares of Harmony Biosciences Holdings took a significant hit, plunging 33% to $20.23, as the company revealed that it failed to meet the primary endpoint for pitolisant in individuals with idiopathic hypersomnia.
The stock reached its lowest point in 52 months, dropping to $18.85 during the session, marking a substantial 60% decline over the past year.
The results of the Phase 3 study showed no significant statistical difference between the pitolisant and placebo groups in terms of excessive daytime sleepiness. However, it’s worth noting that there were positive trends favoring pitolisant across other prespecified endpoints. Further data analyses are still underway.
Of the participants in the study, approximately 88% continued into a 12-month long-term extension study, which is currently ongoing.
When it comes to the safety and tolerability profile of pitolisant in adult patients with idiopathic hypersomnia, no new safety signals were observed. The findings were consistent with the established safety profile of the medication.
Pitolisant, marketed as Wakix in the U.S., is primarily used to treat excessive daytime sleepiness or cataplexy in adult narcolepsy patients.