Shares of US biotech firm ACADIA Pharmaceuticals (Nasdaq: ACAD) plunged 22% to 34.70 in after-hours trading, after it announced that it now plans to submit a New Drug application for Nuplazid (pimavanserin) for the treatment of Parkinson’s disease in the second half of 2015. The company has previously planned to file the NDA by end-2014 or first-quarter 2015.
The decision to move back the planned submission is based on additional time required to complete the preparation of systems to support commercial manufacturing and supply and, in turn, to support the US Food and Drug Administration’s review of Nuplazid. The change in submission timing is not a result of any change to Nuplazid’s clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA, the company stressed.
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