The Shareholders Foundation announces that an investigation on behalf of current long-term investors in shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) was initiated concerning potential breaches of fiduciary duties by certain directors and officers of AcelRx Pharmaceuticals.
Investors who are current long term investors in AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) shares, have certain options and should contact the Shareholders Foundation at email@example.com or call +1(858) 779 – 1554.
The investigation by a law firm for current long term investors in NASDAQ:ACRX stocks follows a lawsuit filed recently against AcelRx Pharmaceuticals Inc over alleged securities laws violations. The investigation on behalf of current long term investors in NASDAQ:ACRX stocks, concerns whether certain AcelRx Pharmaceuticals officers and directors are liable in connection with the allegations made in that lawsuit.
According to that complaint filed in the U.S. District Court for the Northern District of California the plaintiff alleges that between December 2, 2013 and September 25, 2014 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 July 25, 2014, AcelRx Pharmaceuticals Inc announced that the FDA has issued a Complete 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.
On September 26, 2014, AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) 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.
Shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) declined from $8.09 per share on September 8, 2014, to as low as $5.27 per share on September 26, 2014 and continued to decline to as low as $5.22 per share on October 1, 2014.
On October 17, 2014, NASDAQ:ACRX shares closed at $6.74 per share.
Those who purchased shares of AcelRx Pharmaceuticals Inc have certain options and should contact the Shareholders Foundation.
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