INVESTOR ALERT: Law Offices of Howard G. Smith Announces Lead Plaintiff Deadline In The Class Action Lawsuit Against AcelRx P...
21 November 2014 - 2:32AM
Business Wire
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:
- that the Instructions for Use (IFU) for
Zalviso were not designed to adequately address the risk of the
inadvertent misplacement of tablets;
- that the Company had not submitted to
the FDA sufficient data to support the shelf life of the product;
and
- 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.
Law Offices of Howard G. SmithHoward G. Smith, Esquire(215)
638-4847(888)
638-4847howardsmith@howardsmithlaw.comwww.howardsmithlaw.com
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