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    Is JAMA-Lauded Launch-HTN And FDA Feedback Altering The Investment Case For Mineralys Therapeutics (MLYS)?

    Simply Wall St·01/05/2026 19:12:05
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    • Mineralys Therapeutics recently advanced its aldosterone synthase inhibitor program as the Phase 3 Launch-HTN trial of Lorundrostat, which showed significant reductions in systolic blood pressure in treatment-resistant hypertension, was recognized in JAMA’s inaugural “Research of the Year,” and the company received FDA pre-NDA feedback supporting a planned New Drug Application submission.
    • This recognition, combined with the prospect of additional Lorundrostat trial readouts expected in 2026, elevates Mineralys’s profile in the competitive hypertension treatment landscape and highlights growing medical interest in aldosterone-targeted therapies.
    • Against this backdrop, we’ll examine how the JAMA recognition of Launch-HTN could influence Mineralys Therapeutics’ investment narrative and future prospects.

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    What Is Mineralys Therapeutics' Investment Narrative?

    To own Mineralys Therapeutics, you need to believe lorundrostat can convert strong clinical visibility into an approved, commercially relevant hypertension therapy despite ongoing losses and dilution. The JAMA “Research of the Year” recognition and supportive FDA pre-NDA feedback meaningfully sharpen the near-term catalyst roadmap, shifting focus from “can the drug work?” toward “can the company execute on filing, review and launch?” In the short term, the key events are the planned NDA submission and initial regulatory interactions, plus the 2026 readouts from EXPLORE-OSA and other lorundrostat studies that could broaden the asset’s potential footprint. Against this, Mineralys still has no revenue, is spending heavily on development and recently tapped equity markets, so financing needs and regulatory or safety setbacks remain central risks despite the recent news boost.

    However, investors should not overlook the financing and dilution risk that comes with this story. Despite retreating, Mineralys Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much.

    Exploring Other Perspectives

    MLYS 1-Year Stock Price Chart
    MLYS 1-Year Stock Price Chart

    Four Simply Wall St Community fair value estimates for Mineralys span from about US$40 to a very large upper bound, underscoring how far apart individual views can be. Set against this wide range, the strengthened lorundrostat narrative after JAMA recognition and FDA pre-NDA feedback focuses attention on regulatory timing and funding needs as key swing factors for the company’s next phase. You can use these different perspectives to stress-test your own expectations for Mineralys’ execution risk.

    Explore 4 other fair value estimates on Mineralys Therapeutics - why the stock might be worth just $40.47!

    Build Your Own Mineralys Therapeutics Narrative

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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.