• EN

    • -+ 0.00%
    -+ 0.00%
    -+ 0.00%

    Will FDA Approval of DAYBUE STIX for Rett Syndrome Change ACADIA Pharmaceuticals' (ACAD) Narrative

    Simply Wall St·12/25/2025 09:27:27
    Listen to the news
    • In December 2025, ACADIA Pharmaceuticals reported that the FDA had approved DAYBUE STIX, a dye- and preservative-free powder formulation of trofinetide, for treating Rett syndrome in patients aged two and older, based on bioequivalence to the existing oral solution.
    • This new formulation, expected to launch in limited quantities in early 2026 while the original oral solution remains available, broadens dosing flexibility and taste options that could be important for long-term treatment adherence in a rare pediatric and adult population.
    • Next, we’ll examine how the FDA approval of DAYBUE STIX, offering greater dosing flexibility, may reshape ACADIA Pharmaceuticals’ investment narrative.

    These 12 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.

    ACADIA Pharmaceuticals Investment Narrative Recap

    To own ACADIA, you need to believe its focus on CNS and rare diseases can keep translating into growing, diversified revenue beyond NUPLAZID. The DAYBUE STIX approval modestly strengthens the Rett franchise by improving dosing flexibility, but it does not change the central near term catalyst of expanding DAYBUE adoption or the key risk of product concentration and future pricing pressure on NUPLAZID.

    Among recent updates, the November 2025 decision to raise full year 2025 revenue guidance to US$1.070 billion to US$1.095 billion is most relevant, since it anchors expectations for how products like DAYBUE and its new STIX formulation may contribute to sustaining top line momentum as ACADIA leans on a still concentrated product portfolio.

    However, against this backdrop of new formulations and higher guidance, investors should be aware that...

    Read the full narrative on ACADIA Pharmaceuticals (it's free!)

    ACADIA Pharmaceuticals' narrative projects $1.4 billion revenue and $306.0 million earnings by 2028.

    Uncover how ACADIA Pharmaceuticals' forecasts yield a $29.32 fair value, a 5% upside to its current price.

    Exploring Other Perspectives

    ACAD 1-Year Stock Price Chart
    ACAD 1-Year Stock Price Chart

    Six fair value estimates from the Simply Wall St Community range widely from US$18.12 to US$215.22, showing just how far apart individual views can be. When you set those against ACADIA’s dependence on NUPLAZID and the need for DAYBUE, including STIX, to support more balanced growth, it underlines why many readers may want to compare several different assessments of the company’s prospects.

    Explore 6 other fair value estimates on ACADIA Pharmaceuticals - why the stock might be worth 35% less than the current price!

    Build Your Own ACADIA Pharmaceuticals Narrative

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

    No Opportunity In ACADIA Pharmaceuticals?

    Opportunities like this don't last. These are today's most promising picks. Check them out now:

    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.