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Why Axsome Therapeutics (AXSM) Is Up 17.5% After FDA Priority Review for AXS-05 in Alzheimer’s Agitation – And What's Next

Simply Wall St · 6d ago
  • Axsome Therapeutics recently received formal pre-NDA meeting minutes from the FDA supporting a future NDA submission for AXS-12 in narcolepsy-related cataplexy, while the agency also accepted and granted priority review to a supplemental NDA for AXS-05 to treat agitation associated with Alzheimer’s disease with an April 30, 2026 target action date.
  • These regulatory milestones highlight Axsome’s push to broaden its neuroscience franchise into narcolepsy and Alzheimer’s-related agitation, potentially deepening its presence in high unmet-need CNS markets if approvals follow.
  • We’ll now examine how the FDA’s priority review for AXS-05 in Alzheimer’s agitation could reshape Axsome’s late-stage CNS growth narrative.

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Axsome Therapeutics Investment Narrative Recap

To own Axsome, you need to believe its growing CNS portfolio can scale into a broader, more durable business while it works toward profitability. The FDA’s priority review for AXS-05 in Alzheimer’s agitation now stands out as the key near term regulatory catalyst, while the biggest ongoing risk remains execution on commercialization and pricing in a concentrated product base, rather than this specific AXS-12 update.

The most directly relevant development here is the FDA’s priority review for the AXS-05 supplemental NDA in Alzheimer’s agitation, with an April 30, 2026 target action date. This sits alongside Axsome’s plan to file an NDA for AXS-12 in narcolepsy cataplexy, which, if accepted, would add another late stage asset to the catalyst stack but would not, by itself, resolve concerns about payer pressure and margin headwinds.

Yet behind these promising FDA milestones, investors should be aware of the ongoing risk that high SG&A spending and pricing pressure could...

Read the full narrative on Axsome Therapeutics (it's free!)

Axsome Therapeutics’ narrative projects $1.7 billion revenue and $553.3 million earnings by 2028.

Uncover how Axsome Therapeutics' forecasts yield a $181.59 fair value, in line with its current price.

Exploring Other Perspectives

AXSM 1-Year Stock Price Chart
AXSM 1-Year Stock Price Chart

Ten fair value estimates from the Simply Wall St Community span roughly US$31 to US$748 per share, showing very different expectations. Against this spread, Axsome’s reliance on a still narrow, loss making CNS portfolio raises important questions about how quickly new indications and products can translate into sustainable profits, so it is worth weighing several viewpoints before forming a view.

Explore 10 other fair value estimates on Axsome Therapeutics - why the stock might be worth over 4x more than the current price!

Build Your Own Axsome Therapeutics Narrative

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  • A great starting point for your Axsome Therapeutics research is our analysis highlighting 2 key rewards that could impact your investment decision.
  • Our free Axsome Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Axsome Therapeutics' 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.