SAN DIEGO ( TheStreet) -- Acadia Pharmaceuticals (ACAD - Get Report) is taking the express lane to U.S approval for its Parkinson's disease psychosis drug, lifting shares higher in early Thursday trading.
After meeting with the U.S. Food and Drug Administration, Acadia intends to file an approval application for pimavanserin based on data from a successful phase III study completed last year, plus other supportive data.
The company will no longer conduct a confirmatory phase III study that was planned to begin later this month.
The FDA approval filing for pimavanserin as a treatment for Parkinson's psychosis is expected near the end of 2014. FDA will subject the pimavanserin filing to a standard review, which suggests a review cycle of 12 months. If approved, pimavanserin could reach the U.S. market in late 2015.Acadia shares are up 25% to $9.94 in pre-market trading. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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