Neuren lifts 2026 trofinetide income guidance to US$91-93 million
Neuren Pharmaceuticals (ASX: NEU) has upgraded its Neuren guidance for 2026 total income from trofinetide, including royalties and milestone payments, to US$91-93 million from US$53-56 million.
The increase reflects a US$35 million milestone payment earned on the DAYBU launch in Germany in October 2026, together with stronger DAYBUE net sales.
Neuren reported highlights from the Q3 2026 results of its partner, Acadia Pharmaceuticals (Nasdaq: ACAD). Neuren has granted Acadia an exclusive worldwide license for the development and commercialisation of trofinetide. References to DAYBUE net sales include all forms of trofinetide, unless otherwise stated.
The headline numbers from the update:
- Neuren 2026 total income from trofinetide guidance: US$91-93 million (from US$53-56 million)
- Q3 2026 DAYBUE net sales: US$140 million, up 39% on Q3 2025
- Q3 2026 Neuren royalty income: US$16.4 million, up 51% on Q3 2025
- Germany first commercial sale milestone payment: US$35 million
- Acadia 2026 global net sales guidance for trofinetide: US$505-520 million (from US$480-510 million)
Jon Pilcher, CEO
“The Neuren team is excited about the impressive performance of DAYBUE in Q3 2026 and an outlook that continues to strengthen… We are pleased to be able to upgrade our guidance for Neuren’s 2026 total income from trofinetide to US$91 – 93 million.”
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Q3 2026 DAYBUE sales and royalty results
Acadia reported Q3 2026 DAYBUE net sales of US$140 million, up 39% on Q3 2025 and up 12% on Q2 2026. Acadia also increased its full year 2026 global net sales guidance for DAYBUE.
Neuren earned Q3 2026 trofinetide royalty income of US$16.4 million, up 51% on Q3 2025. Royalty income therefore grew faster than net sales over the same period.
Q3 sales growth was driven by strong uptake of DAYBUE STIX by existing patients, as well as new patient starts and patient restarts. More than 50% of US DAYBUE users are already on DAYBUE STIX, up from 40% at the end of Q2.
During Q3, a new US patent was allowed covering weight-banded dosing of trofinetide. It extends US patent protections for DAYBUE and DAYBUE STIX by nearly five years, through March 2041.
Anticipated royalties for the full year 2026 increased to a range of US$56 million to US$58 million, based on Acadia’s full year 2026 DAYBUE net sales guidance of US$505-520 million.
The previous guidance upgrade in August followed record Q2 sales of US$125 million, driven largely by volume from the new STIX powder formulation.
| Metric | Previous guidance | Updated guidance |
|---|---|---|
| Neuren 2026 total income from trofinetide | US$53-56m | US$91-93m |
| Neuren 2026 royalty income | US$53-56m | US$56-58m |
| Acadia 2026 global DAYBUE net sales | US$480-510m | US$505-520m |
Europe launch opens a new growth leg
Germany launch triggers US$35 million milestone
DAYBU was launched in Germany in October 2026, with patients already receiving treatment. The first commercial sale earned Neuren a milestone payment of US$35 million.
CEO Jon Pilcher said the recent launch in Germany “marks the beginning of new growth beyond North America.”
How the Europe licence terms work
Under the licence agreement, Neuren earns from trofinetide in Europe through two mechanisms: tiered royalties on net sales, and sales milestone payments triggered when annual net sales reach set levels.
The territory covers Europe, including all European Union member states as of 13 July 2023 plus the United Kingdom, Iceland, Norway, Switzerland and Liechtenstein.
Royalty rates are payable only on the portion of annual net sales that falls within the applicable range. Each sales milestone payment is payable once only.
| Annual net sales band | Royalty rate (% of net sales) | Net sales in one calendar year | Sales milestone payment |
|---|---|---|---|
| Up to US$150m | 17% | US$120m or more | US$15m |
| Above US$150m, up to US$300m | 20% | US$240m or more | US$30m |
| Above US$300m | 23% | US$400m or more | US$50m |
| n/a | n/a | US$600m or more | US$75m |
The structure steps up royalty rates and adds milestone payments as European sales grow, so Neuren’s returns are weighted towards scale.
What happens next for Neuren and trofinetide
Acadia has completed the Phase 3 study of trofinetide in Rett syndrome in Japan, with results consistent with the LAVENDER Phase 3 study and supportive of a planned regulatory filing. The stated next steps are:
- Acadia continues to pursue a distribution partner in Japan in preparation for a regulatory filing in 2027.
- A potential Japan launch in 2028, subject to regulatory approval.
For investors, the update combines a guidance lift to US$91-93 million, early growth beyond North America through the Germany launch, and US patent protection for DAYBUE and DAYBUE STIX extended through March 2041.
Separately, Neuren’s candidate NNZ-2591 (ercanetide) is in a Phase 3 trial (“Koala”) in Phelan-McDermid syndrome.
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