Acadia Pharmaceuticals Inc. shares rose in the extended session Wednesday after the biotech company said the Food and Drug Administration granted its dementia-related psychosis treatment a special designation to aid in the approval process. Acadia shares advanced 4.4% to $40.86 after hours. The company said the FDA granted a “Breakthrough Therapy Designation” to its drug pimavanserin to treat hallucinations and delusions associated with dementia-related psychosis. Under the designation, the FDA expedites the approval process for drugs that address serious conditions for which there are few to no treatments. Pimavanserin is already FDA-approved to treat hallucinations and delusions in patients with Parkinson’s disease psychosis under the trade name Nuplazid. Acadia said it plans to begin a late-stage clinical trial of pimavanserin in a study expected to enroll about 360 patients with dementia-related psychosis.
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