PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced a remarkable achievement with $186.0 million in net revenue for the third quarter ending September 30, 2024. This milestone has pushed the company past the $2 billion mark in cumulative net revenues since launching WAKIX® for adult narcolepsy in November 2019.
During a recent Investor Day, Harmony Biosciences emphasized its evolution into a self-sustaining biotech company with a robust pipeline of late-stage developments. This includes plans to submit a supplemental New Drug Application for pitolisant in treating idiopathic hypersomnia by the end of 2024, backed by promising long-term efficacy data.
The company is also advancing its next-generation pitolisant programs, including Pitolisant-GR and Pitolisant-HD, set to enhance their offerings in the sleep/wake domain. These developments are designed to improve efficacy and safety, aiming for regulatory approvals extending into the 2040s.
Harmony is making strides in rare epilepsies too, with EPX-100 in a pivotal Phase 3 trial for Dravet Syndrome and upcoming trials for Lennox-Gastaut Syndrome. Additionally, Harmony anticipates pivotal results for ZYN-002, targeting Fragile X syndrome, by mid-2025.
“We are building on our success in sleep/wake with a strategy focused on continuous innovation, patient impact, and long-term value creation for our shareholders,” said Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences. He highlighted the company’s commitment to addressing unmet medical needs in CNS disorders, promising significant value to both patients and shareholders.
Financially, Harmony reported a 16% year-over-year increase in net product revenues, driven largely by the strong performance of WAKIX. The average number of patients using WAKIX increased to approximately 6,800, reflecting ongoing demand.
Looking ahead, Harmony maintains its guidance for 2024 net product revenue between $700 million and $720 million. The company continues to invest in research and development, with increased expenses reflecting its commitment to expanding its therapeutic reach.
As of the end of the third quarter, Harmony held $504.7 million in cash, cash equivalents, and investments, highlighting its financial health and readiness to support its ambitious growth plans.
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