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Neuren Pharmaceuticals Secures Positive Recommendation for Daybue From EMA Committee

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Neuren Pharmaceuticals (ASX:NEU) secured a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use, which recommended approval of Daybue for treating neurobehavioral symptoms of Rett syndrome in patients aged five years and older, according to a Monday filing with the Australian bourse.

The company said that if the European Commission grants final approval in the coming months, Daybue would become the first approved therapy for this indication across the European Union, as well as Iceland, Liechtenstein, and Norway, per the filing.

It added that under its exclusive global licensing agreement with Acadia Pharmaceuticals, it is eligible to receive $35 million upon the first commercial sale in Europe, up to $170 million in sales milestone payments, and tiered royalties ranging from the mid-teens to low-20% of net sales, the filing said.

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