The Shareholders Foundation announces that an investigation for investors in shares of NASDAQ:ACRXshares is ongoing concerning whether certain statements regarding AcelRx Pharmaceuticals’ business, its prospects and its operations were materially false and misleading at the time they were made.
Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) declined from as high as $12.69 per share in early 2014 to as low as under $3 per share on May 13, 2015.
Investors who purchased shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 – 1554.
The investigation by a law firm concerns whether AcelRx Pharmaceuticals Inc and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
Response Letter for the Company’s new drug application (“NDA”) for Zalviso™ (sufentanil sublingual tablet system). The Company is currently reviewing the FDA’s comments and requests contained in the CRL and plans to discuss these requests with theFDA. AcelRx Pharmaceuticals said that the Complete Response Letter contains requests for additional information on the Zalviso System to ensure proper use of the device. AcelRx Pharmaceuticals said that additional bench testing will be required and human factors testing may be required to address certain items in the Complete Response Letter.
Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) dropped from as high as $11.38 per share during July 25, 2014, to $6.14 per share on July 28, 2014,
On September 26, 2014, AcelRx Pharmaceuticals Inc provided an update on the plans for the resubmission of the Company’s New Drug Application (NDA) for Zalviso™ (sufentanil sublingual tablet system). Among other things, AcelRx Pharmaceuticals Inc said that the timing of the filing of the NDA could be later than the first quarter of 2015 and that theFDA communicated that the planned resubmission will qualify as a Class 2 resubmission with a review period of six months.
On October 1, 2014, a lawsuit was filed against AcelRx Pharmaceuticals Inc over alleged Securities Laws Violations. The plaintiff claims that defendants made allegedly false and/or misleading statements and/or allegedly failed to disclose between December 2, 2013 and September 25, 2014 that the Instructions for Use (IFU) for Zalviso were not designed to adequately address the risk of the inadvertent misplacement of tablets, that AcelRx Pharmaceuticals Inc had not submitted to the U.S. Food and Drug Administration (“FDA”) sufficient data to support the shelf life of the product, and 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 March 9, 2015, AcelRx Pharmaceuticals Inc provided an update on the timing and potential content of the resubmission of the New Drug Application (“NDA”) for Zalviso. AcelRx Pharmaceuticals Inc said that late last week it received correspondence from the Food and Drug Administration (“FDA”) stating that in addition to the bench testing and two Human Factors studies it has performed, an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures. Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) declined to as low as $3.95 per share on March 12, 2015.
On May 4, 2015, a news reports stated that AcelRx Pharmaceuticals Inc said a division of the FDA had rejected the company’s request for a meeting to discuss the need for an additional trial of its pain drug device, Zalvizo. Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) declined on May 13, 2015 to as low as $2.96 per share.
On May 26, 2015, NASDAQ:ACRX shares closed at $3.43 per share.
Those who are former employees of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North – Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com