Neuren Pharmaceuticals experienced a sharp decline in share value during morning trade on the ASX, following a negative trend vote from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The decision relates to Acadia Pharmaceuticals’ marketing authorisation application for trofinetide, a treatment for Rett syndrome, a rare genetic neurological and developmental disorder that affects brain development. Neuren is a biopharmaceutical company focused on developing therapies for neurodevelopmental disorders. Acadia Pharmaceuticals is a licensee of Neuren.
Shares in Neuren fell by 9.9 per cent to $14.64, after hitting an intraday low of $12.66. The CHMP’s vote followed Acadia’s recent oral explanation regarding the application. The final outcome regarding the treatment is anticipated upon formal adoption of the CHMP decision in February.
Acadia Pharmaceuticals has indicated its intention to request a re-examination of the decision if required, adhering to EU regulations that allow a 15-day period for such requests. This mechanism provides an opportunity for Acadia to present further information and arguments to the CHMP.
Neuren’s chief executive officer, Jon Pilcher, expressed his disappointment with the vote, describing it as “frustrating”. He reiterated the company’s support for Acadia’s planned re-examination and underscored their continued dedication to serving the Rett syndrome community.
