ACADIA Pharmaceuticals Stock Trading Halted Today
March 29 2016 - 7:05AM
Business Wire
FDA Advisory Committee to Review
NUPLAZID™ (Pimavanserin) New Drug Application for the
Treatment of Parkinson’s Disease Psychosis
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system (CNS) disorders, today announced that NASDAQ has
halted trading of the company’s common stock.
The U.S. Food and Drug Administration (FDA) Psychopharmacologic
Drugs Advisory Committee (PDAC) is meeting today to review
NUPLAZID™ (pimavanserin) for the treatment of patients with
psychosis associated with Parkinson’s disease.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET.
The briefing materials can be found on the FDA website at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm475314.htm.
About The Psychopharmacologic Drugs Advisory Committee
The Committee is an independent panel of experts that reviews
and evaluates data regarding the safety and effectiveness of
marketed and investigational human drug products for use in the
practice of psychiatry and related fields and makes appropriate
recommendations to the FDA.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, about one
million people in the United States and from four to six million
people worldwide suffer from Parkinson’s disease. An estimated 40
percent of these patients have Parkinson’s disease psychosis, which
is characterized by hallucinations and delusions, a diminished
quality of life, and significant caregiver burden.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a
selective serotonin inverse agonist preferentially targeting 5-HT2A
receptors that play an important role in psychosis. The New Drug
Application for NUPLAZID for Parkinson’s disease psychosis is
currently under review by the FDA. NUPLAZID is an oral medicine
that, if approved, would be taken once a day (34 mg). ACADIA
discovered NUPLAZID and holds worldwide rights to this new chemical
entity. The trade name NUPLAZID has been provisionally accepted by
the FDA. The safety and efficacy of NUPLAZID have not been fully
evaluated by any regulatory authority.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines to address unmet
medical needs in central nervous system disorders. ACADIA has a
pipeline of product candidates led by NUPLAZID™ (pimavanserin), for
which we have submitted a New Drug Application (NDA) in Parkinson’s
disease psychosis to the FDA and which has the potential to be the
first drug approved in the United States for this condition. The
FDA has classified the NUPLAZID NDA as having Priority Review
status. ACADIA maintains a website at www.acadia-pharm.com to which
we regularly post copies of our press releases as well as
additional information and through which interested parties can
subscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include but are not limited to statements related to the
progress and timing of ACADIA’s drug discovery and development
programs, including clinical trials, the benefits to be derived
from ACADIA’s product candidates, in each case including NUPLAZID
(pimavanserin), and the potential for NUPLAZID to be the first drug
approved in the United States for Parkinson’s disease psychosis, if
approved at all. These statements are only predictions based on
current information and expectations and involve a number of risks
and uncertainties. Actual events or results may differ materially
from those projected in any of such statements due to various
factors, including the risks and uncertainties inherent in drug
discovery, development, approval and commercialization, and the
fact that past results of clinical trials may not be indicative of
future trial results. For a discussion of these and other factors,
please refer to ACADIA’s annual report on Form 10-K for the year
ended December 31, 2015 as well as ACADIA’s subsequent filings with
the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. This caution is made under the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. All forward-looking statements are qualified in their
entirety by this cautionary statement and ACADIA undertakes no
obligation to revise or update this press release to reflect events
or circumstances after the date hereof, except as required by
law.
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version on businesswire.com: http://www.businesswire.com/news/home/20160329005493/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy(858)
558-2871orMedia Contact:Taft and PartnersTed Deutsch(609)
578-8765ted@taftandpartners.com
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