Harmony Biosciences is expanding its pipeline beyond its core narcolepsy drug Wakix to build a broader neuroscience franchise. The company is advancing pitolisant into late-stage trials for idiopathic hypersomnia, Prader-Willi syndrome, and myotonic dystrophy type 1, while developing gastro-resistant and high-dose formulations to improve tolerability and target fatigue and sleep inertia, with top-line data expected in 2027 and a target action date in 2028. Harmony is also entering orexin-2 receptor agonism with BP1.15205, a once-daily candidate for narcolepsy, and rare epilepsy through EPX-100, which is enrolling in two global Phase III trials for Lennox-Gastaut syndrome and Dravet syndrome. The company faces increasing competition from multiple orexin-2 receptor agonists nearing approval, which could heighten payer scrutiny and pressure differentiation. HRMY carries a Zacks Rank #3 (Hold) with a Value Score of A and a Growth Score of B, but a Momentum Score of D suggests investors may need patience as the market awaits clearer pipeline data.
Harmony Biosciences HoldingsPipeline expansion with pitolisant in multiple indications and orexin-2 agonist BP1.15205, with late-stage trials and expected data.
Jazz Pharmaceuticals PLCHarmony's pipeline expansion, including orexin-2 agonism, may increase competition for Jazz's narcolepsy franchise.
Alkermes Plc