Law Offices of Howard G.
Smith reminds investors of AcelRx Pharmaceuticals, Inc. (“AcelRx” or
the “Company”) (NASDAQ:ACRX) that 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”), have until December 1, 2014, to file a
motion to be appointed as lead plaintiff in the shareholder lawsuit.
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.
The Complaint alleges that defendants made false and/or misleading
statements and/or failed to disclose during the Class Period, including:
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that the Instructions for Use (IFU) for Zalviso were not designed to
adequately address the risk of the inadvertent misplacement of tablets;
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that the Company had not submitted to the FDA sufficient data to
support the shelf life of the product; and
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as a result of the foregoing, that 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 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 December 1, 2014, 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