ACADIA Pharmaceuticals shares fell 24% in midday trading on Thursday after saying Wednesday it plans to submit its NUPLAZID new drug application to treat Parkinson’s disease psychosis in 2H15 instead of Q115, as previously planned.
Near midday, shares of ACAD were down 24% to $34.00 on heavy volume of 8.6 million shares. Average daily volume is 1.5 million shares.
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 U.S. Food and Drug Administration’s (FDA) review of NUPLAZID, it said 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, it noted.
Separately, it said Uli Hacksell, Ph.D., has retired as its CEO and resigned from its Board of Directors, effective Wednesday. Steve Davis, Executive Vice President, Chief Financial Officer and Chief Business Officer, has been appointed as Interim Chief Executive Officer.