Core Insights - Acadia Pharmaceuticals anticipates a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding its marketing application for trofinetide to treat Rett syndrome [1][2] Company Overview - Acadia was informed of a negative trend vote on its marketing application for trofinetide, which may delay potential approval in the European Union [2] - The company plans to seek a re-examination of the CHMP opinion once it is formally adopted [2] Product Information - Trofinetide is intended for treating Rett syndrome, a rare neurodevelopmental disorder affecting approximately one in 10,000-15,000 female births globally [3] - The FDA approved trofinetide for treating Rett syndrome in adults and pediatric patients aged two years and older in 2023, marketed as Daybue in the United States [4] Financial Performance - Acadia's shares have increased by 8.6% over the past six months, while the industry has seen a rally of 18.8% [5] - The company expects long-term growth from its products Nuplazid and Daybue, targeting combined net sales of $1.7 billion by 2028, with approximately $1 billion from Nuplazid and $700 million from Daybue [8][9] Market Position - Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis, with patent protection until 2038 [10] - In the first nine months of 2025, Nuplazid generated $505.7 million in sales, reflecting a 13% year-over-year increase [10] - Daybue has also shown promising sales, with $281.8 million in sales during the first nine months of 2025, up 12% year-over-year [11] New Product Launch - The FDA recently approved Daybue Stix, an oral solution for treating Rett syndrome, which will be launched in a limited capacity in Q1 2026, followed by broader availability in Q2 2026 [12][13]