Acadia Pharma down after negative EU trend vote on neurological disorder drug

Shares of Acadia Pharmaceuticals ACAD.O fall 8.2% to $24 in extended trading

Co says it was informed by the Committee for Medicinal Products for Human Use of the European Medicines Agency of a negative trend vote on its marketing application for trofinetide for the treatment of Rett syndrome, following its recent CHMP oral explanation

Rett syndrome is a rare genetic neurological and developmental disorder that affects the way the brain develops

Acadia says it intends to request a re-examination of the opinion by the CHMP upon its formal adoption

"Negative CHMP trend vote on Daybue (brand name of trofinetide) is disappointing, and reduces likelihood ACAD can garner a potentially meaningful LT (long-term) revenue source," RBC Capital Markets says

RBC adds, with our analysis indicating that 20% of negative CHMP opinions are eventually overturned, there remains a possibility that the drug could ultimately gain approval

Stock down 2.2% in 2025