Law
Offices of Howard G. Smith announces that a class action lawsuit has
been filed in the United States District Court for the Northern District
of California on behalf of a class (the “Class”) of investors of AcelRx
Pharmaceuticals, Inc. (“AcelRx” or the “Company”) (NASDAQ:ACRX) who
purchased or otherwise acquired AcelRx’s common stock and/or call
options, or sold/wrote AcelRx’s put options between December 2, 2013 and
September 25, 2014, inclusive (the “Class Period”).
AcelRx is a specialty pharmaceutical company focused on the development
and commercialization of innovative therapies for the treatment of acute
and breakthrough pain. The Company plans to commercialize its product
candidates in the United States and license the development and
commercialization rights to its product candidates for sale outside of
the United States through strategic partnerships and collaborations. One
such product is Zalviso, which consists of sufentanil tablets delivered
by the Zalviso System, a needle-free, handheld, patient-administered,
pain management system (collectively, “Zalviso”).
The Complaint alleges that defendants made false and/or misleading
statements and/or failed to disclose during the Class Period: (1) that
the Instructions for Use (IFU) for Zalviso were not designed to
adequately address the risk of the inadvertent misplacement of tablets;
(2) that the Company had not submitted to the FDA sufficient data to
support the shelf life of the product; and (3) that, as a result of the
foregoing, Defendants’ statements about Zalviso, including the drug’s
regulatory approval and financial prospects, were materially false and
misleading at all relevant times and/or lacked a reasonable basis.
On July 25, 2014, after the market closed, AcelRx announced that it had
received a Complete Response Letter (“CRL”) from the FDA regarding its
New Drug Application for Zalviso. According to the Company, the FDA
requested additional information on the Zalviso System to ensure proper
use of the device, including changes to the Instructions for Use for the
device and additional data to support the shelf life of the product. On
this news, shares of AcelRx declined $4.44 per share, nearly 41%, to
close on July 28, 2014, at $6.39 per share, on unusually heavy volume.
On September 26, 2014, AcelRx revealed that the resubmission process for
its Zalviso NDA would not be complete until the first quarter of 2015 at
the earliest. According to the Company, the FDA also communicated that
the planned resubmission will qualify as a Class 2 resubmission with a
review period of six months. On this news, shares of AcelRx declined
$1.31 per share, over 19%, to close on September 26, 2014, at $5.41 per
share, on unusually heavy volume.
If you are a member of the Class described above, you have until
December 1, 2014, to move the Court to serve as lead plaintiff, if you
meet certain legal requirements. To be a member of the Class you need
not take any action at this time; you may retain counsel of your choice
or take no action and remain an absent member of the Class. If you wish
to learn more about this action, please contact Howard G. Smith,
Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite
112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll
Free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com,
or visit our website at http://www.howardsmithlaw.com.
Copyright Business Wire 2014