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Neuren Pharmaceuticals’ Partner Acadia Gains FDA Approval for New Rett Syndrome Treatment

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Neuren Pharmaceuticals’ Partner Acadia Gains FDA Approval for New Rett Syndrome Treatment

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Neuren Pharmaceuticals Limited ( (AU:NEU) ) has provided an update.

Neuren Pharmaceuticals announced that its partner, Acadia Pharmaceuticals, has received FDA approval for DAYBUE STIX, a new powder formulation of trofinetide for Rett syndrome, offering patients and caregivers more flexibility and choice. This approval, based on bioequivalence studies, ensures comparable efficacy and safety to the existing oral solution. DAYBUE STIX is expected to be available in early 2026, with Neuren receiving royalties on sales, potentially impacting its market position and providing new options for stakeholders.

The most recent analyst rating on (AU:NEU) stock is a Buy with a A$23.00 price target. To see the full list of analyst forecasts on Neuren Pharmaceuticals Limited stock, see the AU:NEU Stock Forecast page.

More about Neuren Pharmaceuticals Limited

Neuren Pharmaceuticals Limited is focused on developing new drug therapies for serious neurological disorders that emerge in early childhood, with limited or no approved treatment options. The company has developed DAYBUE® (trofinetide) and DAYBUE STIX (trofinetide), both approved by the US FDA for the treatment of Rett syndrome. Neuren has partnered with Acadia Pharmaceuticals Inc. for the global development and commercialization of trofinetide. Additionally, Neuren is working on NNZ-2591 for various neurodevelopmental disorders, which has received ‘orphan drug’ designation in the US and EU.

YTD Price Performance: 52.08%

Average Trading Volume: 406,516

Technical Sentiment Signal: Buy

Current Market Cap: A$2.41B

For an in-depth examination of NEU stock, go to TipRanks’ Overview page.

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