-- Designation underscores the significant unmet need for new treatment options for Alzheimer’s disease psychosis, a serious condition with no FDA-approved therapies

-- RADIANT Phase 2 enrollment completed, with topline results now expected September to October 2026 and Phase 3 screening and enrollment underway

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).

Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need, with the goal of getting important new drugs to patients earlier.

Acadia is also providing an update on RADIANT, its development program evaluating remlifanserin for the treatment of hallucinations and delusions associated with ADP. Enrollment in the Phase 2 portion of the program has been completed, and the Company now expects to report topline results in September to October 2026. Consistent with RADIANT’s operationally seamless design, screening and enrollment are underway in the Phase 3 studies.