PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has announced robust preliminary net product revenues for the fourth quarter and full year of 2024, with figures reaching $201 million and $714 million, respectively. These results reflect approximately 23% year-over-year growth for WAKIX® (pitolisant), now in its fifth year on the market, as the company positions itself for a milestone-packed 2025.
“2025 is a pivotal year for Harmony Biosciences, as we focus on unlocking the full potential of our catalyst-rich neuroscience pipeline,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “Building upon our foundation of strong and continued revenue growth for WAKIX, our multi-franchise pipeline has come into focus with value-creating catalysts expected each and every quarter this year. We are entering 2025 with strong momentum and a clear path toward long-term growth, building a company with the potential to deliver over $3 billion in net revenue going forward.”
The 2025 revenue guidance for WAKIX is projected to be between $820 million and $860 million, with the company aiming for a $1 billion-plus milestone. Meanwhile, Harmony forecasts a steady stream of advances in its pipeline, including pivotal clinical trials and regulatory decisions.
Key Catalysts in 2025 Include:
- Q1: FDA decision on file acceptance for pitolisant’s sNDA to treat idiopathic hypersomnia, with a potential approval later in the year.
- Q2: Presentation of preclinical data for BP1.15205 (OX2R agonist) at the SLEEP 2025 conference.
- Q3: Topline Phase 3 data for ZYN002 targeting Fragile X syndrome, which could become the first approved treatment for this condition.
- Q4: Launch of the pivotal Phase 3 trial for Pitolisant-HD for narcolepsy, tackling the unmet need for greater efficacy in treating excessive daytime sleepiness and cataplexy.
Harmony’s robust pipeline includes up to six Phase 3 clinical programs by the end of 2025, with a focus on indications such as Lennox-Gastaut syndrome and narcolepsy. The company aims to introduce at least one new product or indication annually through 2028, reaffirming the potential to generate over $3 billion in revenue with its diversified offerings.
With its strong revenue performance and ambitious development initiatives, Harmony Biosciences is poised to advance its position in the neuroscience and rare disease sectors while meeting critical patient needs.
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