What happened
Shares of Harmony Biosciences (HRMY 1.35%) were down more than 34% as of 12:15 p.m. on Friday after the healthcare company reported phase 3 data on its therapy Pitolisant to treat idiopathic hypersomnia (IH), a rare and chronic neurological disease.
So what
Harmony is a pharmaceutical company that focuses on neurological disorders. IH patients suffer sleepiness even after a full night's sleep. While the company said it saw some positive signs in Pitolisant's phase 3 trial, the drug did not meet its primary endpoint of statistically significant decrease on the Epworth Sleepiness Scale (ESS) compared to a placebo.
The drug, marketed as Wakix in the U.S., is approved by the Food and Drug Administration (FDA) to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. It is the company's lead therapy, and Harmony is looking to broaden its indications. The company said it will crunch the data further before deciding its next step regarding Pitolisant as a potential IH therapy. Harmony also has a phase 3 trial scheduled this year for Pitolisant as a therapy for a Prader-Willi Syndrome, a genetic disorder caused by a loss of function of specific genes on chromosome 15 that leads patients to feel constant hunger.
Now what
The setback hides what has been a strong year for Harmony. In the second quarter, the company reported revenue of $134.2 million, up 25% year over year, as well as net income of $34.3 million, or $0.56 in earnings per share (EPS), compared to $23.5 million in net income and $0.39 in EPS in the same period last year. The growth is due to more patients regularly using Wakix.
Harmony, on Wednesday, said it had completed its purchase of Zynerba Pharmaceuticals, obtaining its lead therapy candidate, Zygel, a pharmaceutically manufactured synthetic cannabidiol. The drug is in a phase 3 trial to treat fragile X syndrome, a genetic disorder that can lead to mild or moderate intellectual disability.
