Why Is Sleep Disorder Related Harmony Biosciences Stock Trading Lower Today?

Harmony Biosciences Holdings Inc HRMY announced topline results from the INTUNE Phase 3 study of pitolisant in patients with idiopathic hypersomnia (IH).

Idiopathic hypersomnia is a central disorder of hypersomnolence, primarily characterized by the irresistible need to sleep and waking up non-refreshed despite the prolonged sleep duration.

Approximately 83% of patients who completed the 8-week open-label treatment period with pitolisant were responders and experienced a robust clinical response, with an average Epworth Sleepiness Scale (ESS) change from baseline of – 9.4 points. 

A positive trend favoring pitolisant was observed during the 4-week double-blind, randomized withdrawal period. However, no statistically significant difference was observed between pitolisant and placebo groups on ESS, the primary endpoint. 

Positive trends favoring pitolisant were also observed across additional prespecified endpoints, including the IHSS, which approached statistical significance, and the SlQ. 

Further data analyses are being conducted. Approximately 88% of patients in the study continued into a 12-month long-term extension study, which is ongoing. 

The safety and tolerability profile of pitolisant was consistent with the established safety profile, and no new safety signals were observed.

Pitolisant is marketed as Wakix in the U.S. for excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. Pitolisant is not approved for IH and is currently being evaluated as an investigational agent in adult patients with IH.

Price Action: HRMY shares are down 36.20% at $19.30 on the last check Friday.