Core Insights - Harmony Biosciences announced positive results from its pivotal bioequivalence study for pitolisant gastro-resistant formulation, indicating its potential as a next-generation treatment for narcolepsy [1][2] - The company plans to submit a New Drug Application (NDA) in early 2026, targeting a PDUFA date in Q1 2027, with utility patent applications filed for exclusivity until 2044 [1][3] Bioequivalence Study Results - The pivotal bioequivalence study confirmed that 17.8mg of pitolisant gastro-resistant is bioequivalent to existing 17.8mg WAKIX tablets, with AUC and Cmax ratios of 108.46% and 99.65% respectively [2] - No new safety or tolerability issues were reported, and 100% of patients successfully initiated treatment at the therapeutic dose without the need for titration [2] Market Position and Future Developments - The progress on pitolisant gastro-resistant formulation highlights the accelerating momentum of the pitolisant franchise, which is nearing blockbuster status in narcolepsy [3] - Harmony is also developing pitolisant HD, a high-dose formulation aimed at enhancing efficacy for excessive daytime sleepiness and other symptoms in narcolepsy and idiopathic hypersomnia [3] Company Overview - Harmony Biosciences is focused on developing innovative therapies for rare neurological diseases, emphasizing a commitment to patients with unmet medical needs [19]