Neuren shares rise on treatment accepted for Canada review
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The news: Canada's health department will review Neuren Pharmaceuticals' Rett syndrome treatment trofinetide after accepting a new drug submission by Neuren's Nasdaq-listed partner Arcadia Pharmaceuticals.
The numbers: Neuren shares were trading 2.9% higher at $19.83 by 10:30am AEST, following the announcement. Over the last 12 months the company's shares has risen 40.5%.
Neuren also released its 2023 annual report, which declared profit after tax of $157.1 million compared to $200,000 in 2022. This was driven by revenue from Acadia of $232 million comprising royalty of $27 million, a milestone payment of $59 million and $149 million from the expanded worldwide agreement between the two companies.
The context: Health Canada has granted a priority review for the trofinetide submission, which is supported by results from a positive Phase 3 study.
Acadia has exclusive rights to develop and commercialise trofinetide globally. Under the terms of Neuren's agreement with Acadia, the development and commercialisation of the drug is fully funded by Acadia.
Neuren said that if marketing authorisation is granted by Health Canada, any potential sales of trofinetide in Canada will be combined with sales in the US for the purpose of determining Neuren's entitlement to milestone payments and royalties.
Earlier this year, shares in Neuren plunged after after US activist short-seller Culper Research published a report that said Acadia misrepresented the safety profile of trofinetide, which was granted approval by the US Food and Drug Administration in March 2023.
The sources: ASX announcement, ASX announcement
