Remlifanserin (ACP-204) - (RADIANT)

November 4, 2026: Acadia Pharmaceuticals (NASDAQ: ACAD) reported Q3 2026 results and multiple pipeline/regulatory catalysts. For remlifanserin, the company said Phase 3-enabling topline Phase 2 RADIANT data in Alzheimer’s disease psychosis showed consistent efficacy trends at the 60 mg dose across four psychosis scales in the full study population, with favorable safety/tolerability; additional data will be presented at the Clinical Trials on Alzheimer’s Disease conference on November 17, 2026. Acadia is continuing Phase 3 development in AD psychosis, received FDA Fast Track designation for remlifanserin in Lewy body dementia psychosis, and guided to a Phase 2 readout in LBD psychosis in Q4 2027. ACP-211 Phase 2 data in major depressive disorder are expected in 2H 2027.

For trofinetide/DAYBUE, the European Commission approved DAYBU for neurobehavioral symptoms of Rett syndrome in adults and pediatric patients age 5+ in the EU in August 2026; Acadia launched in Germany in early October. The Phase 3 trofinetide study in Rett syndrome in Japan was completed with results consistent with LAVENDER, supporting a planned regulatory filing in 2027 and potential launch in 2028, subject to approval. A new U.S. patent allowance extends trofinetide protection to March 2041.

Q3 sales were $342 million total, including DAYBUE $140 million and NUPLAZID $202 million. Acadia raised 2026 DAYBUE sales guidance to $505-$520 million.