• In early February 2026, ACADIA Pharmaceuticals reported that the EMA’s CHMP issued a negative trend vote on its Marketing Authorization Application for trofinetide (DAYBUE) in Rett syndrome, and the company now plans to formally seek a re-examination under EU procedures.
• This setback highlights the regulatory hurdles ACADIA faces in bringing DAYBUE to European patients, even as it is already commercialized elsewhere for Rett syndrome.
• We’ll now examine how the CHMP’s negative trend vote and ACADIA’s planned re-examination request could reshape the company’s investment narrative.

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ACADIA Pharmaceuticals Investment Narrative Recap

To own ACADIA, you need to believe the company can keep growing a focused CNS and rare-disease franchise while managing its reliance on NUPLAZID and DAYBUE. The CHMP’s negative trend vote for DAYBUE in Rett syndrome adds regulatory uncertainty around a key international growth lever, but the main near term catalyst remains upcoming earnings and guidance, with the biggest current risk still centered on concentration in a narrow product base and pricing pressure in the U.S. over time.

The EMA feedback arrives shortly after ACADIA’s December 2025 news that the FDA approved DAYBUE STIX, a powder formulation that could broaden U.S. use in Rett syndrome. Together, these updates frame DAYBUE as both a meaningful opportunity and a source of regulatory and commercial execution risk, with progress in one major market now contrasted by a potential delay or revision to ACADIA’s plans in Europe.

But beneath the positive DAYBUE and NUPLAZID story, investors should also be aware of...

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

Uncover how ACADIA Pharmaceuticals' forecasts yield a $31.21 fair value, a 42% upside to its current price.

Exploring Other Perspectives

Some of the lowest ranked analysts were already more cautious, assuming revenue grows to about US$1.3 billion but earnings fall toward US$57 million, and the CHMP setback could further test that more pessimistic view around regulatory and execution risk in DAYBUE’s global rollout.

Explore 8 other fair value estimates on ACADIA Pharmaceuticals - why the stock might be worth over 6x more 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.

• A great starting point for your ACADIA Pharmaceuticals research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision.
• Our free ACADIA Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate ACADIA Pharmaceuticals' 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.