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    Milestone Pharmaceuticals (MIST) Is Down 16.3% After First-in-Decades At-Home PSVT Drug Approval - Has The Bull Case Changed?

    Simply Wall St·12/17/2025 15:19:15
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    • Milestone Pharmaceuticals recently received U.S. Food and Drug Administration approval for CARDAMYST (etripamil) nasal spray, its first commercial product for at-home conversion of acute symptomatic paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults, with retail availability targeted for early 2026.
    • This is the first new FDA-approved PSVT treatment in over 30 years and introduces a self-administered, out-of-hospital option for more than two million affected Americans, potentially changing how these arrhythmia episodes are managed.
    • We’ll now examine how FDA approval of CARDAMYST as an at-home PSVT treatment reshapes Milestone Pharmaceuticals’ investment narrative.

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    What Is Milestone Pharmaceuticals' Investment Narrative?

    For Milestone, the big picture now hinges on whether CARDAMYST can evolve the company from a cash-burning developer into a commercially credible cardiovascular player. FDA approval removes the binary PSVT regulatory overhang and, in the near term, shifts the key catalysts to launch execution, payer coverage, and any early prescription traction as retail availability approaches in early 2026. The announcement has already refocused market debate: instead of asking “if” CARDAMYST reaches patients, investors are asking “how effectively” and “how fast,” especially given Milestone’s lack of revenue to date and a share price that still trades well below consensus targets. At the same time, the approval heightens existing risks around funding ongoing losses, potential dilution, and the company’s ability to support both a commercial rollout and its AFib-RVR program with limited resources.

    However, investors also need to weigh how Milestone funds launch and pipeline commitments from here. Despite retreating, Milestone Pharmaceuticals' shares might still be trading above their fair value and there could be some more downside. Discover how much.

    Exploring Other Perspectives

    MIST 1-Year Stock Price Chart
    MIST 1-Year Stock Price Chart
    The Simply Wall St Community’s five fair value estimates span roughly US$5.68 to US$56.79 per share, reflecting sharply different expectations. With CARDAMYST now approved yet Milestone still loss making and highly valued on book, you are seeing how widely opinions can differ and why it helps to test your own view against multiple perspectives.

    Explore 5 other fair value estimates on Milestone Pharmaceuticals - why the stock might be a potential multi-bagger!

    Build Your Own Milestone Pharmaceuticals Narrative

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

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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.