Harmony Biosciences Highlights Record WAKIX Growth, Advances Orexin and Epilepsy Pipeline

Harmony Biosciences Highlights Record WAKIX Growth, Advances Orexin and Epilepsy Pipeline Written by MarketBeat August 14, 2026 Key Points WAKIX delivered record quarterly growth , strengthening Harmony Biosciences’ commercial position and providing funding and flexibility for pipeline investments and potential business-development deals. BP-205 showed encouraging early orexin-agonist results , including dose-proportional exposure, an approximately 25-hour half-life and no observed cardiovascular, hepatic or visual safety signals in initial studies. Harmony plans additional data in late 2026, a sleep-deprivation study with results expected in early 2027, and multiple Phase II trials beginning in mid-2027. The company is advancing several late-stage programs: Phase III EPX-100 studies in Dravet and Lennox-Gastaut syndromes are expected to produce results in 2027, while gastro-resistant pitolisant faces an April 27 PDUFA date and higher-dose pitolisant studies could expand treatment into idiopathic hypersomnia.

Harmony Biosciences NASDAQ: HRMY highlighted record quarterly performance for its narcolepsy treatment WAKIX and outlined development plans across its orexin, epilepsy and pitolisant lifecycle-management programs during Piper Sandler’s virtual CNS Symposium. Peter Anastasiou, the company’s chief operating officer, said WAKIX’s seventh year on the market continued to demonstrate its role in narcolepsy treatment and the company’s commercial capabilities. He said the product’s performance supports investment in pipeline programs, including BP-205, and provides flexibility for potential business-development transactions.

BP-205 Data Support Broad Orexin Development Plans Chief Medical Officer Kumar Budur discussed initial clinical findings for BP-205, an orexin 2 receptor agonist being developed for narcolepsy and potentially other central nervous system indications. He described BP-205 as having a novel chemical scaffold, high potency and selectivity, and preclinical safety findings that did not indicate hepatotoxicity or cardiotoxicity concerns. Harmony reported results from a randomized, double-blind, placebo-controlled single-ascending-dose study in 72 healthy volunteers. Doses ranged from 0.2 milligrams to 6 milligrams. Budur said the study showed a time to maximum concentration of 30 to 75 minutes, dose-proportional exposure across the evaluated range and a half-life of approximately 25 hours. The company believes those pharmacokinetic characteristics could support once-daily dosing. Budur said once-daily administration could be beneficial for patient convenience and adherence, while the longer half-life could help maintain wakefulness later in the day. In the single-ascending-dose study, reported adverse events included headache in approximately 10% of participants, fatigue in 4% and diarrhea in 3%. The company said it did not observe cardiovascular, hepatic or visual disturbances. Harmony has completed dosing in a multiple-ascending-dose study, where it observed target-engagement adverse events including insomnia and polyuria. Budur said insomnia was neither severe nor sustained, and no visual adverse events had been seen in the multiple-ascending-dose dataset to date. Harmony expects to disclose the full multiple-ascending-dose dataset in the fourth quarter. It has opened an investigational new drug application in the U.S. and plans to begin a sleep-deprived healthy-volunteer study, with top-line data expected in early 2027. Anastasiou said Harmony and partner Bioprojet intend to pursue a broad orexin strategy, potentially including a portfolio of orexin agonists. The company is evaluating potential uses in cognition, attention, mood and fatigue, in addition to narcolepsy and idiopathic hypersomnia. Ha...