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Acadia raises DAYBUE guidance to $505–520M as German launch follows EU approval

🇺🇸 Acadia Pharmaceuticals Inc (ACAD) · Wed 04 Nov 2026

Acadia Pharmaceuticals reported Q3 2026 revenue of $342 million and said DAYBUE (trofinetide) for Rett syndrome has launched in Germany after European Commission approval in August.

Acadia Pharmaceuticals reported third-quarter 2026 results on 4 November, with total revenue of $342 million. DAYBUE contributed $140 million and NUPLAZID $202 million.

The company raised its full-year DAYBUE sales guidance to between $505 million and $520 million. The summary of the results does not give the previous range.

On the regulatory side, Acadia said the European Commission approved DAYBUE (trofinetide) for Rett syndrome in August. The product launched in Germany in October, the first European market the company has announced.

Acadia also reported that the US Food and Drug Administration has granted Fast Track designation to remlifanserin for psychosis associated with Lewy body dementia. Fast Track is an FDA programme intended to speed the development and review of medicines for serious conditions with unmet need. It does not indicate that a product is approved or will be.

Separately, the company said it has received a new US patent for trofinetide, extending protection through March 2041.

What it means for your team

  • Market-access teams following Rett syndrome should note that DAYBUE became commercially available in Germany in October, following European Commission approval in August.
  • Regulatory teams tracking neuropsychiatric pipelines can note the FDA Fast Track designation for remlifanserin in Lewy body dementia psychosis. It is a development-stage designation, not an approval.
  • The new US trofinetide patent, running to March 2041, is relevant to long-term exclusivity planning for the US market.

Company's press release (SEC filing): Acadia Pharmaceuticals Inc ↗

Article written by VigiEye from the official source (Acadia Pharmaceuticals Inc). Claims are the company's own. AI-assisted; check the source before acting.

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