Glancy Binkow & Goldberg LLP, representing investors of AcelRx
Pharmaceuticals, Inc. (“AcelRx” or the “Company”) (NASDAQ: ACRX),
has filed a class action lawsuit in the United States District Court for
the Northern District of California on behalf of a class (the “Class”)
comprising those 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”).
Please contact Casey
Sadler or Lesley
Portnoy at (310) 201-9150 or (888) 773-9224, or at shareholders@glancylaw.com
to discuss this matter. If you inquire by email, please include your
mailing address, telephone number and number of shares purchased.
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 may move the Court
no later than sixty (60) days from the date of this Notice, 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, or if you have any questions concerning this
announcement or your rights or interests with respect to these matters,
please contact Casey
Sadler, Esquire, or Lesley
Portnoy, Esquire, of Glancy Binkow & Goldberg LLP, 1925 Century Park
East, Suite 2100, Los Angeles, California 90067, at (310) 201-9150 or
(888) 773-9224, by e-mail to shareholders@glancylaw.com,
or visit our website at http://www.glancylaw.com.
If you inquire by email, please include your mailing address, telephone
number and number of shares purchased.
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Copyright Business Wire 2014