Neuren shares dive despite EU regulatory progress
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More news: Neuren Pharmaceuticals was the worst performing ASX 200 company in early trading after its US partner Acadia Pharmaceuticals applied for approval to market its Rett syndrome treatment, trofinetide, in the European Union.
Neuren shares were down 6% to $11.28 by 11:15am AEDT, extending losses of more than 50% over the last 12 months.
Neuren's Rett syndrome therapy moves closer to EU approval
The news: Neuren Pharmaceuticals' Rett syndrome treatment, trofinetide, is a step closer to receiving regulatory approval in the European Union, after its US partner Acadia Pharmaceuticals submitted a marketing authorisation application to the European Medicines Agency (EMA).
The numbers: Under its worldwide licence agreement with Acadia, Neuren is eligible for total milestone payments of up to USD170 million ($274 million) for Europe sales, plus tiered royalties on net sales of "mid-teen to low twenties per cent".
The context: Acadia anticipates potential approval for trofinetide in the EU in Q1 2026. If granted marketing authorisation, the treatment will be the first and only approved therapy for Rett syndrome — a rare genetic neurodevelopmental disorder that affects brain development — in the EU.
Acadia expects initiating managed access programs in Europe in the second quarter of 2025.
Trofinetide, sold under the brand name Daybue, is already approved in the US and Canada for Rett syndrome.
What they said: "We are pleased to see the achievement of this very important milestone towards potentially bringing trofinetide to the Rett community in Europe," said Neuren CEO Jon Pilcher.
The source: ASX announcement
