Neuren Pharmaceuticals Ltd
Neuren Pharmaceuticals Limited is an Australia-based biopharmaceutical company developing therapies for neurodevelopmental disorders.
The business
Neuren Pharmaceuticals Limited is an Australia-based biopharmaceutical company developing therapies for neurodevelopmental disorders. The Company is developing new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options. The Company’s product DAYBUE (trofinetide) is used to treat Rett syndrome in adults and pediatric patients two years of age and older. The United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted orphan drug designation to the Company for trofinetide in Fragile X syndrome. Its second product, NNZ-2591, is in phase II clinical trials in Phelan-McDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome and Prader-Willi syndrome. The Company has granted an exclusive worldwide license to Acadia Pharmaceuticals Inc. for the development and commercialization of NNZ-259 for Rett syndrome and Fragile X syndrome.
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Latest news
Neuren Pharmaceuticals to receive significant royalties on back of DAYBUE sales surge
Neuren Pharmaceuticals (ASX: NEU) is expecting to receive increasing royalty payments from its US partner Acadia Pharmaceuticals, with sales of the recently launched DAYBUE treatment continuing to surge. The Australian pharmaceutical company developed a unique Rett syndrome treatment and granted an exclusive worldwide licence to Acadia for the development and commercialisation of its trofinetide breakthrough, […]
Tabcorp and Entain rumoured to bid for PointsBet, FDA approves Neuren’s Rett drug and IPH dives on cyber security breach
Sources close to PointsBet’s (ASX: PBH) Australian arm have revealed potential acquisition bids are in the works from one of the world’s largest betting and gaming groups Entain (LSE: ENT) and another from major Australian wagering group Tabcorp (ASX: TAH). Potential bids from Entain and Tabcorp follow PointsBet’s confirmation in late December it was in […]
Neuren Pharmaceuticals receives FDA approval for world-first drug to treat Rett syndrome
Melbourne-based Neuren Pharmaceuticals (ASX: NEU) has announced its North American partner Acadia Pharmaceuticals (NASDAQ: ACAD) has received US Food and Drug Administration (FDA) approval for Neuren’s lead candidate Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients. The drug is the world’s first and only approved treatment for Rett syndrome and is expected […]
Neuren Pharma granted orphan drug status for treatment of Phelan-McDermid, Pitt Hopkins and Angelman syndromes
A drug developed by Neuren Pharmaceuticals (ASX: NEU) to treat debilitating childhood neurodevelopmental disorders has been granted orphan drug designation by the US Food and Drug Administration. Drug candidate NNZ-2591 has previously demonstrated positive results in separate mouse models of Phelan-McDermid, Pitt Hopkins and Angelman syndromes. Currently there are no drug therapies approved for these […]
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