Neuren Says Exclusive Global Licensee Secures European Commission Marketing Authorization for Neurodevelopmental Disorder Drug

MT Newswires Live

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Neuren Pharmaceuticals (ASX:NEU) said the European Commission gave marketing authorization for Daybu, or trofinetide, for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older to its exclusive global licensee for trofinetide, Acadia Pharmaceuticals, according to a Tuesday Australian bourse filing.

Daybu is now authorized to be marketed in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, per the filing.

Under the companies' license agreement, for Europe, Neuren is entitled to receive $35 million following first commercial sale, potential sales milestone payments of up to $170 million on achievement of escalating annual net sales thresholds, and tiered royalties from mid-teens to low-20s percentage of net sales.

Acadia earlier said that a commercial launch in Germany is expected in the December quarter.

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