Why ACADIA Pharmaceuticals Shares Are Trading Higher Today? - ACADIA Pharmaceuticals (NASDAQ:ACAD)

Ahead of Acadia Pharmaceuticals Inc's ACAD FDA AdComm meeting on Friday, the agency officials released their briefing documents, revealing a mixed bag of opinions.
The company's resubmitted supplemental New Drug Application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP) has a target action date of August 4.
Initially, the FDA considered the Phase 2 trial, dubbed Study 019, insufficiently adequate and well-controlled, one of many reasons for the CRL, agency documents said.
Related: Analysts Say Acadia's Negative Pain Data Increases Focus On Pimavanserin For Alzheimer's-Related Psychosis.
Study 019 involved patients whose psychotic symptoms were not clear or who received "exclusionary medications" when randomized into the study, the documents said.
Acadia reconducted its primary endpoint analysis to measure the impact of these deviations, and the results came in favor of pimavanserin.
Also See: Acadia Slims Nuplazid Label Expansion Application For Alzheimer's Disease Psychosis.
"At this time, the Agency has determined that the study was designed with features that could allow it to be considered an adequate and well-controlled trial suitable for regulatory decision making," the documents read.
"However, questions remain related to whether the methods of assessment of subjects' response are well defined and reliable."
Price Action: ACAD shares are up 12.8% at $18.33 during the market session on the last check Wednesday.

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