• EN

    • -+ 0.00%
    -+ 0.00%
    -+ 0.00%

    Will EPX-100’s Phase 3 Seizure-Reduction Data Shift Harmony Biosciences Holdings’ (HRMY) Rare Epilepsy Narrative?

    Simply Wall St·12/13/2025 16:39:04
    Listen to the news
    • Earlier this week, Harmony Biosciences Holdings reported initial open-label extension data from its Phase 3 ARGUS trial of EPX-100 in Dravet syndrome, showing around a 50% median reduction in motor seizure frequency and generally good long-term tolerability.
    • The emerging benefit-risk profile of EPX-100, including multi-year safety data and meaningful seizure reduction in a hard-to-treat population, could meaningfully enhance Harmony’s rare epilepsy portfolio if future results align with these early findings.
    • We’ll now explore how EPX-100’s early Phase 3 extension results, particularly the sustained seizure reductions, may influence Harmony’s broader investment narrative.

    This technology could replace computers: discover 27 stocks that are working to make quantum computing a reality.

    Harmony Biosciences Holdings Investment Narrative Recap

    To own Harmony Biosciences, you need to believe it can steadily broaden beyond WAKIX by turning its neurology pipeline into durable, cash-generating franchises. The new EPX-100 open-label data supports that diversification story but does not materially change the near term focus on WAKIX performance and late stage readouts like ZYN002, while clinical and regulatory risk across the portfolio remains front of mind.

    The recent positive bioequivalence results for the pitolisant gastro resistant formulation are especially relevant here, as they reinforce Harmony’s effort to extend and defend its core pitolisant franchise while EPX-100 and other pipeline assets mature, shaping how investors may think about timing and balance of future catalysts relative to existing concentration risk.

    Yet even as enthusiasm builds around EPX-100’s potential, investors should be aware that...

    Read the full narrative on Harmony Biosciences Holdings (it's free!)

    Harmony Biosciences Holdings' narrative projects $1.2 billion revenue and $333.5 million earnings by 2028.

    Uncover how Harmony Biosciences Holdings' forecasts yield a $44.55 fair value, a 10% upside to its current price.

    Exploring Other Perspectives

    HRMY 1-Year Stock Price Chart
    HRMY 1-Year Stock Price Chart

    Seven members of the Simply Wall St Community see Harmony’s fair value between US$42 and about US$197, highlighting sharply varied expectations. Set this against Harmony’s reliance on WAKIX as the dominant revenue source and you can see why it pays to explore several competing views before forming a thesis.

    Explore 7 other fair value estimates on Harmony Biosciences Holdings - why the stock might be worth just $42.28!

    Build Your Own Harmony Biosciences Holdings Narrative

    Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

    • A great starting point for your Harmony Biosciences Holdings research is our analysis highlighting 4 key rewards that could impact your investment decision.
    • Our free Harmony Biosciences Holdings research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Harmony Biosciences Holdings' overall financial health at a glance.

    Want Some Alternatives?

    Early movers are already taking notice. See the stocks they're targeting before they've flown the coop:

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.