Neuren share price in focus after DAYBU wins EU approval for Rett syndrome

The Neuren Pharmaceuticals Ltd (ASX: NEU) share price is in focus after its global partner, Acadia Pharmaceuticals, secured European approval for DAYBU (trofinetide) – the first treatment for Rett syndrome in the EU. Neuren stands to receive US$35 million upon the drug’s first commercial sale in Europe, plus potential milestone payments.

What did Neuren report?

• The European Commission has granted marketing authorisation for DAYBU (trofinetide) for Rett syndrome.
• DAYBU is the first and only approved treatment for Rett syndrome in the European Union.
• Neuren to receive US$35 million from the first European commercial sale, with milestone payments up to US$170 million.
• Tiered royalties from mid-teens to low 20s percent of net sales are also expected under the partnership.
• Commercial launch in Germany is targeted for early Q4 2026.

What else do investors need to know?

The European approval means DAYBU can be marketed across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. This milestone further extends the reach of trofinetide, which is already approved in the United States, Canada, and Israel.

Neuren’s other clinical program, NNZ-2591, is progressing with a Phase 3 clinical trial for Phelan-McDermid syndrome and open-label extension studies. Each of Neuren’s drug development programs has been granted “orphan drug” status in both the US and EU.

What did Neuren management say?

Neuren CEO Jon Pilcher said:

We are delighted for the Rett syndrome community in Europe, who, until now, have had no approved treatment for this devastating condition. The European Commission’s approval of DAYBU is particularly rewarding for Neuren given our long-standing commitment to developing therapies for serious neurological disorders with profound unmet need. We look forward to seeing our partner Acadia make DAYBU available for Rett patients and families in Europe.

What’s next for Neuren?

With European marketing authorisation, Acadia plans to launch DAYBU in Germany in early Q4 2026, which will trigger Neuren’s first commercial milestone payment. Ongoing development of NNZ-2591, now in late-stage trials for several neurodevelopmental disorders, remains a key priority for future growth.

Neuren continues to target serious neurological conditions where few approved treatments exist, aiming to advance both its existing partnerships and its internal drug pipeline.

Neuren share price snapshot

The Neuren Pharmaceuticals share price has outperformed the S&P/ASX 200 index (ASX: XJO) over the past 12 months with a gain of approximately 27%.

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The post Neuren share price in focus after DAYBU wins EU approval for Rett syndrome appeared first on The Motley Fool Australia.

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Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips. This article was prepared with the assistance of Large Language Model (LLM) tools for the initial summary of the company announcement. Any content assisted by AI is subject to our robust human-in-the-loop quality control framework, involving thorough review, substantial editing, and fact-checking by our experienced writers and editors holding appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content published by The Motley Fool Australia.