INVESTOR ALERT: Class Action Lawsuit Against AcelRx Pharmaceuticals, Inc. Announced by Law Offices of Howard G. Smith
October 03 2014 - 7:15PM
Business Wire
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.
Law Offices of Howard G. SmithHoward G. Smith,
Esquire215-638-4847888-638-4847howardsmith@howardsmithlaw.comwww.howardsmithlaw.com
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