Acadia Pharmaceuticals (Nasdaq: ACAD), a developer of treatments for neurological and rare diseases, revealed on Monday that it has received U.S. Food and Drug Administration Fast Track designation for remlifanserin, an investigational treatment for hallucinations and delusions associated with Alzheimer's disease psychosis.

This designation supports accelerated development and review of therapies addressing serious conditions with unmet medical needs.

The company said it has completed Phase 2 enrollment in its RADIANT development program and expects topline results between September and October 2026. Screening and enrollment for Phase 3 studies are also underway as the company advances remlifanserin through development.

Remlifanserin is a selective 5-HT2A receptor inverse agonist being evaluated as a potential treatment for Alzheimer's disease and Lewy body-associated psychosis, targeting symptoms without direct dopamine receptor blockade associated with some existing therapies.