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    Why Praxis Precision Medicines (PRAX) Is Up 7.1% After FDA Alignment On 2026 NDA Path

    Simply Wall St·12/16/2025 10:16:06
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    • In recent days, Praxis Precision Medicines reported positive clinical outcomes for its EMBOLD study of relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathies, alongside FDA alignment on an early 2026 New Drug Application submission and a streamlined, single-arm EMBRAVE3 registrational study for elsunersen in SCN2A-DEE.
    • Taken together, these updates position Praxis as a rare neurology company advancing both a potential first-in-class small molecule and an antisense oligonucleotide targeting ultra-rare pediatric epilepsies and essential tremor, areas with limited treatment options today.
    • Against this backdrop, we’ll explore how FDA alignment on relutrigine’s path to an early 2026 NDA filing may reshape Praxis’s investment narrative.

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    What Is Praxis Precision Medicines' Investment Narrative?

    To own Praxis today, you have to believe in its ability to translate a concentrated neurology pipeline into real, de‑risked commercial assets before the cash burn and dilution catch up with it. The latest relutrigine efficacy win and FDA alignment on an early 2026 NDA, paired with the streamlined single‑arm EMBRAVE3 design for elsunersen, pull key catalysts forward and narrow some development risk in ultra‑rare epilepsies. At the same time, the essential tremor NDA plan for ulixacaltamide keeps a much broader opportunity in focus. That mix helps explain the very large share price move and richer valuation multiples, but it does not remove execution risk: Praxis is still loss‑making, has a history of dilution, and relies heavily on a small number of late‑stage assets hitting their marks on timing, data quality and regulatory acceptance.

    However, one risk in particular could matter more than the rest for shareholders. Praxis Precision Medicines' shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

    Exploring Other Perspectives

    PRAX 1-Year Stock Price Chart
    PRAX 1-Year Stock Price Chart

    Two Simply Wall St Community fair value views span roughly US$419 to US$2,945 per share, underlining how far apart individual expectations sit. Set that against Praxis’s recent rally and the heightened dependence on a handful of late stage neurology readouts, and you can see why some investors may want to weigh multiple viewpoints before deciding how much risk they are comfortable with.

    Explore 2 other fair value estimates on Praxis Precision Medicines - why the stock might be worth over 10x more than the current price!

    Build Your Own Praxis Precision Medicines 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.