|ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Plunged 21% On Surprised News Of Delay in Application|
|By Marilyn Mullen|
|Thursday, 12 March 2015 13:33|
Shares of ACADIA Pharmaceuticals Inc.(NASDAQ:ACAD) tumbled 21% in Thursday’s session on hefty volume after the company surprised its shareholders by announcing that it will delay the New Drug Application for its experimental Parkinson's disease psychosis drug nuplazid (pimavanserin) from this quarter to sometime in the 2nd half of the year.
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD)., a biopharmaceutical company has today provided an update on the planned timing of its NUPLAZIDTM (pimavanserin) New Drug Application (NDA) submission. It is planning to submit its NUPLAZID NDA for the treatment of Parkinsons disease psychosis in the second half of 2015. The company had previously planned to submit the NDA in the first quarter of 2015. The change in submission timing is not a result of any change to NUPLAZIDs clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA. Steve Davis, Interim Chief Executive Officer of ACADIA said that the additional time is required to complete the readiness of their commercial manufacturing systems.
ACADIA Pharmaceuticals had announced that Uli Hacksell, Ph.D., has retired as its Chief Executive Officer and resigned from its Board of Directors. Steve Davis, Executive Vice President, Chief Financial Officer and Chief Business Officer of ACADIA, has been appointed as Interim Chief Executive Officer of the company.
ACADIA has discovered NUPLAZID and holds worldwide rights to this new chemical entity. The trade name NUPLAZID has been provisionally accepted by the FDA. ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by NUPLAZID (pimavanserin), for which they have reported positive Phase III trial results in Parkinsons disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. Pimavanserin is also in Phase II development for Alzheimers disease psychosis and has successfully completed a Phase II trial in schizophrenia.