Neuren Pharmaceuticals shares rocket after inching closer to EU approval
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More news: Shares in Neuren Pharmaceuticals surged in morning trade after the biopharmaceutical company reported positive feedback from Europe’s Committee for Medicinal Products for Human Use, leading to a recommendation for the EU’s commercial authorisation of its Rett syndrome drug Daybue.
Shares jumped 29.4% to $15.79 at 11:04am AEST.
Neuren Pharmaceuticals receives EU recommendation for Rett syndrome treatment
The news: The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Union (EU) authorise Neuren Pharmaceuticals’ flagship Rett syndrome treatment, Daybue, bringing the company a step closer to expanding its European footprint.
The context: This follows a positive opinion issued by the CHMP following the Daybue re-examination procedure for the treatment of neurobehavioral symptoms of Rett syndrome in adults and paediatric patients.
If granted, Daybue would be the first therapy approved for Rett syndrome in the EU, granting market authorisation across all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
Neuren will be entitled to receive a USD35 million ($50 million) payment from its partner Acadia Pharmaceuticals following the first commercial sale in Europe. The company is also eligible for sales milestone payments of up to USD170 million alongside tiered royalties ranging from the mid-teens to the low-20% of net sales.
What they said: “With no approved treatment currently available in the EU, approval of Daybue would represent an important step forward for patients, caregivers and the wider Rett syndrome community profoundly impacted by this devastating condition,” CEO Jon Pilcher said.
The source: ASX
