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Neuren Pharmaceuticals Limited ( (AU:NEU) ) has provided an update.
Neuren Pharmaceuticals disclosed that its licensee Acadia Pharmaceuticals has received a negative trend vote from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the marketing authorization application for trofinetide to treat Rett syndrome in the European Union, following an oral explanation to the committee. Acadia plans to pursue a formal re-examination of the opinion once adopted, arguing that clinical trial results and real‑world experience in more than 1,000 patients underpin trofinetide’s benefits and aligning with Neuren’s view that the decision is frustrating for the Rett community; the outcome will influence Neuren’s ability to extend the commercial reach of its lead therapy into the EU market and may affect expectations around access to new treatment options for European patients with this rare neurological disorder.
The most recent analyst rating on (AU:NEU) stock is a Buy with a A$19.50 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 an Australian biopharmaceutical company developing new drug therapies for serious neurological and neurodevelopmental disorders that emerge in early childhood and have few or no approved treatment options. Its lead asset, trofinetide (marketed in the US as DAYBUE and DAYBUE STIX for Rett syndrome), is licensed globally to Acadia Pharmaceuticals, while its second candidate, NNZ-2591, is in Phase 2 development for Phelan-McDermid, Pitt Hopkins and Angelman syndromes, all of which have received orphan drug designation in the US and EU.
YTD Price Performance: -10.32%
Average Trading Volume: 337,268
Technical Sentiment Signal: Buy
Current Market Cap: A$2.11B
For detailed information about NEU stock, go to TipRanks’ Stock Analysis page.