Neuren Pharmaceuticals (NEU.AX) announced that its partner, Acadia Pharmaceuticals (ACAD), will request a re-examination of the opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The opinion relates to the Marketing Authorization Application for trofinetide, intended for the treatment of Rett syndrome in patients aged two years and older. The previously signaled CHMP trend vote was confirmed in the formal vote.
Trofinetide is already approved in the United States, Canada, and Israel, where it represents the first and only treatment available for Rett syndrome.
Commenting on the development, Acadia's Chief Executive Officer Catherine Owen Adams said:"While we are disappointed by the CHMP's recommendation to refuse approval, we continue to be encouraged by the meaningful benefits trofinetide has demonstrated for people living with Rett syndrome. The strong engagement and positive feedback we have seen from patients, caregivers, and clinicians in the Rett community reinforce our belief in the treatment's clinical value. We remain committed to working constructively with EU regulators to explore next steps and to bring this therapy to patients."
ACAD closed Monday's regular trading session at $22.81 down $1.75 or 7.13%. But in after-hours trading, the stock gained $0.01 or 0.04%.
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