INVESTOR ALERT: Glancy Binkow & Goldberg LLP Reminds Investors of the Lead Plaintiff Deadline in the Class Action Lawsuit Aga...
07 November 2014 - 7:34AM
Business Wire
Glancy Binkow & Goldberg LLP 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 filed in
the United States District Court for the Northern District of
California.
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 that:
- the Instructions for Use (IFU) for
Zalviso were not designed to adequately address the risk of the
inadvertent misplacement of tablets;
- 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,
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 December 1, 2014, to serve as lead
plaintiff; however, you must 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 Lesley Portnoy, Esquire, or Casey Sadler, Esquire, of
Glancy Binkow & Goldberg LLP, 1925 Century Park East, Suite
2100, Los Angeles, California 90067, at (310) 201-9150, 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.
This press release may be considered Attorney Advertising in
some jurisdictions under the applicable law and ethical rules.
Glancy Binkow & Goldberg LLP, Los Angeles, CALesley
PortnoyCasey Sadler310-201-9150888-773-9224shareholders@glancylaw.comwww.glancylaw.com
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