Do EPX-100 ARGUS Data Hint At A New Strategic Axis For Harmony Biosciences (HRMY)?

• Earlier this month, Harmony Biosciences announced initial open-label extension data from its Phase 3 ARGUS trial of EPX-100 in Dravet syndrome, showing clinically meaningful seizure reductions and a generally favorable safety profile over long-term treatment.
• Beyond the seizure data, the twice-daily liquid EPX-100, derived from a proprietary zebrafish screening platform targeting 5HT-2 serotonin receptors, highlights Harmony’s push into rare, treatment-resistant epilepsies such as Dravet and Lennox-Gastaut syndromes.
• We’ll now examine how these early ARGUS extension results for EPX-100 could reshape Harmony’s investment narrative around pipeline breadth and growth.

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Harmony Biosciences Holdings Investment Narrative Recap

To own Harmony Biosciences, you need to believe WAKIX can keep funding a broader neurology portfolio while late stage assets improve the company’s concentration risk. The new EPX-100 ARGUS extension data adds credibility to Harmony’s rare epilepsy push, but WAKIX still looks like the key near term catalyst and the largest risk if competition or pricing pressure increases. At this stage, the EPX-100 data does not appear to change that balance in a material way.

Among recent announcements, the progress on pitolisant gastro resistant (GR) and its planned NDA in early 2026 stands out next to EPX-100. GR, with potential patent protection to 2044, matters because it could extend the economic life of pitolisant and partially offset long term concerns about WAKIX exclusivity, which remains one of the central issues for Harmony’s valuation and investor expectations around future earnings resilience.

Yet investors should also be aware that if WAKIX faces faster than expected pressure from new therapies or generics, especially before...

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 18% upside to its current price.

Exploring Other Perspectives

Seven members of the Simply Wall St Community currently estimate Harmony’s fair value between US$42 and about US$197, reflecting very different expectations. Against that range, the early EPX-100 seizure reduction data may influence how you think about Harmony’s ability to diversify beyond WAKIX and support longer term earnings power.

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.

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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.

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