By Maria Armental
Acadia Pharmaceuticals (ACAD) won't be seeking regulatory
approval for its lead drug candidate to treat Parkinson's disease
psychosis until the second half of the year.
The announcement came as the San Diego biopharmaceutical
company, which focuses on treatment of central nervous system
disorders, said longtime Chief Executive Uli Hacksell has resigned
from his post, effective immediately.
No reason was specified in a filing with the Securities and
Exchange Commission. The company said in a news release Mr.
Hacksell had retired.
Executive Vice President Stephen R. Davis, who has taken over
the top post on an interim basis, said in a conference call with
analysts Wednesday afternoon that Mr. Hacksell had discussed with
board "for some time" retiring
Asked about Mr. Hacksell's leaving the board, Mr. Davis said,
"When a CEO leaves the organization, it's very common that they
also step off the board."
Mr. Davis, 53 years old, also serves as chief financial officer
and chief business officer, has taken over on an interim basis.
Shares plunged nearly 22% to $35 in recent after-hours
trading.
Acadia said additional time to seek regulatory approval was
needed to make sure it is ready to support production and supply of
its candidate treatment pimavanserin, which would be commercialized
as Nuplazid. The Food and Drug Administration granted the drug
breakthrough therapy designation last year, which means the FDA
will act on the application within 60 days of receipt.
Acadia had planned to file a new drug application in the first
quarter.
"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 said in a statement.
"Speaking quite frankly, the company didn't start the process
early enough to get those things in place," Mr. Davis said during
the conference call.
Under the terms of an agreement with Mr. Hacksell, the former
chief executive will receive a $36,000 lump sum payment and an
additional $580,000, broken down in monthly installments, for
consulting work over the next 1 1/2 years.
Write to Maria Armental at maria.armental@wsj.com
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