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Biotech Stocks Facing FDA Decision In April 2021

ACADIA Pharmaceuticals
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals Inc. (ACAD) will know on April 3, 2021 whether or not the FDA approves the expanded use of NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis.

NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson’s disease psychosis.

Dementia is highly prevalent, affecting approximately 8 million people in the U.S., and is expected to grow as the population ages. Approximately 30% or 2.4 million people experience dementia-related psychosis.

Currently, there is no approved, safe, effective treatment for symptoms linked to dementia-related psychosis.

The drug recorded annual net sales of $441.8 million in 2020 compared to $339.1 million in 2019.

Early this month, the FDA had notified the company of certain deficiencies in the application seeking expanded approval of NUPLAZID for the treatment of hallucinations and delusions associated with dementia-related psychosis. However, the regulatory agency has not yet provided any information on the nature of the deficiencies.

ACAD closed Friday’s (Mar.26, 2021) trading at $25.86, down 0.61%.