Harmony Biosciences announces results from pitolisant bioequivalence study

Harmony Biosciences (HRMY) announced results from its bioequivalence study evaluating pitolisant gastro-resistant formulation. With findings from both the pivotal BE and dosing optimization studies, Harmony is on track to submit a new drug application for pitolisant GR in early 2026, targeting a PDUFA date in Q1 2027. With utility patent applications filed for pitolisant GR with potential exclusivity to 2044, Harmony is positioned to extend the pitolisant franchise into the mid-2040s. The BE study confirmed that 17.8mg of pitolisant GR is bioequivalent to existing 17.8mg Wakix tablets. The pitolisant GR vs. WAKIX AUC and Cmax ratios were 108.46 h*ng/mL and 99.65 ng/mL, respectively. No new safety or tolerability issues were reported. Importantly, the topline data from the dosing optimization study of pitolisant GR showed 100% of patients successfully initiated treatment at the therapeutic dose of 17.8mg, eliminating the need for dose titration. This progress on pitolisant GR underscores the accelerating momentum of the pitolisant franchise, which is rapidly approaching blockbuster status in narcolepsy alone.