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

Harmony Biosciences (NASDAQ:HRMY) reported record quarterly performance for its narcolepsy treatment WAKIX and laid out plans for multiple programs across orexin, epilepsy and pitolisant lifecycle-management during Piper Sandler’s virtual CNS Symposium. Chief Operating Officer Peter Anastasiou said WAKIX’s seventh year on the market supports the company’s pipeline investment, including BP-205. Chief Medical Officer Kumar Budur shared early BP-205 data for an orexin 2 receptor agonist being developed for narcolepsy and potentially other CNS indications. In a randomized, double-blind, placebo-controlled single-ascending-dose study of 72 volunteers (0.2–6 mg), time to maximum concentration was 30–75 minutes, exposure was dose-proportional, and half-life was about 25 hours, supporting once-daily dosing. Adverse events included headache (~10%), fatigue (4%) and diarrhea (3%). Harmony expects to disclose full multiple-ascending-dose data in Q4 and plans additional Phase II studies in mid-2027.