Harmony Biosciences announced that its pivotal bioequivalence study for the pitolisant gastro‑resistant (GR) formulation has produced positive top‑line data, confirming that a 17.8 mg dose of pitolisant GR is bioequivalent to the existing 17.8 mg WAKIX® tablets. The study also demonstrated that patients can start treatment at the therapeutic dose without the need for dose titration, a key patient‑experience improvement that could enhance adherence and broaden the product’s market reach.
The dosing‑optimization study that underpins this milestone enrolled 120 adults with narcolepsy and followed them for 12 weeks. All participants successfully initiated therapy at 17.8 mg, and no new safety or tolerability signals emerged. By eliminating titration, the GR formulation simplifies the prescribing pathway and reduces the risk of dose‑related adverse events, positioning Harmony to capture a larger share of the narcolepsy market.
Financially, the GR milestone builds on Harmony’s strong Q3 2025 performance, where WAKIX net revenue rose 29% YoY to $239.5 million from $186.0 million in Q3 2024. The company’s full‑year 2025 revenue guidance was raised to $845–$865 million, reflecting confidence in continued growth of both the existing product and the new GR formulation. The GR launch is expected to add a new revenue stream that could accelerate the company’s path to blockbuster status for pitolisant.
Patent filings for the GR formulation were also completed, with utility applications that could extend exclusivity to 2044. The extended protection strengthens Harmony’s competitive moat by safeguarding the product against generic entry for nearly two decades, while the GR’s improved dosing profile may give it a pricing advantage over other narcolepsy therapies.
Market reaction to the announcement was positive, with analysts noting the regulatory milestone and the potential upside from the new product line. The announcement reinforced investor confidence in Harmony’s pipeline momentum and its ability to translate clinical success into commercial growth.
Management emphasized the significance of the milestone, with CEO Jeffrey M. Dayno stating, “The GR study confirms our strategy of delivering differentiated, patient‑centric therapies that expand our franchise and reinforce our long‑term competitive position.” Chief Medical Officer Kumar Budur added, “Eliminating dose titration will improve patient adherence and outcomes, positioning pitolisant as the preferred choice for narcolepsy.”
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