BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that it is investigating potential claims on behalf of purchasers of the securities of AcelRx Pharmaceuticals, Inc. (“AcelRx” or the “Company”) (NASDAQ:ACRX) concerning possible violations of federal securities laws. The investigation is focused on certain statements issued by AcelRx concerning the Company’s operations and financial prospects. AcelRx is a development-stage specialty pharmaceutical company, focused on therapies for the treatment of acute and breakthrough pain.
The investigation is related to AcelRx’s announcement that the Company’s New Drug Application (NDA) for Zalviso™ (sufentanil sublingual tablet system) will qualify as a Class 2 resubmission with a review period of six months. According to a press release issued by AcelRx on September 26, 2014, the Company is targeting resubmission of the NDA for first quarter 2015 or later, subject to feedback from the FDA. Following this announcement, AcelRx shares dropped nearly 20%, or $1.31 per share, on extremely heavy volume.
The Company previously announced in a July 28, 2014, regulatory filing that it anticipated resubmitting the NDA by the end of 2014, after receiving a Complete Response Letter from the FDA requesting additional information on the Zalviso System concerning proper use of the device, optical system errors, changes to the instructions for use of the device, and submission of additional data to support the shelf life of the product.
If you purchased AcelRx securities between December 2, 2013 and September 26, 2014, if you have information or would like to learn more about these claims, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, 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 firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.