Harmony Biosciences (HRMY) Is Up 7.6% After GR Pitolisant Bioequivalence Win and Patent Runway Push

• Harmony Biosciences recently reported positive pivotal bioequivalence results for its gastro-resistant (GR) pitolisant formulation, confirming equivalence to existing WAKIX tablets and supporting plans to file a New Drug Application in early 2026 with a potential review decision in the first quarter of 2027.
• By pairing these GR data with high-dose pitolisant development and patent applications that could extend exclusivity to 2044, Harmony is reinforcing the long-term durability of its pitolisant franchise in sleep and wake disorders.
• Next, we will examine how the GR bioequivalence success and extended patent runway could reshape Harmony’s broader investment narrative.

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Harmony Biosciences Holdings Investment Narrative Recap

To own Harmony, you need to believe WAKIX can remain a strong cash engine while the company methodically broadens its sleep and neuro portfolio. The GR bioequivalence win supports the most visible near term catalyst, a 2026 NDA filing, and modestly reduces long term exclusivity risk, but it does not change the key short term risk that Harmony is still highly dependent on a single product.

The recent start of the Phase 1 trial for BP1.15205, an orexin 2 receptor agonist, is especially relevant here, since it directly addresses competitive and concentration risks around WAKIX by opening a potential second respiratory sleep and wake franchise if the data are successful.

Yet, investors should also weigh how emerging orexin therapies could pressure WAKIX’s share and pricing over time, which is something every shareholder should be aware of...

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 16% upside to its current price.

Exploring Other Perspectives

Seven Simply Wall St Community valuations for Harmony range from about US$42 to US$197 per share, showing how far opinions can stretch. You can weigh those views against the central question of whether new pitolisant formulations and orexin programs will meaningfully reduce Harmony’s dependence on WAKIX as its core profit source.

Explore 7 other fair value estimates on Harmony Biosciences Holdings - why the stock might be worth over 5x more than the current price!

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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