San Diego, CA -- (SBWIRE) -- 08/28/2012 -- An investigation on behalf of investors in shares of Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) was announced over potential violations of securities laws over certain statements made in connection with Chelsea Therapeutics’ new drug Northera.
Investors who purchased shares of Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) between November 3, 2008 and March 28, 2012, have certain options and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
The investigation by a law firm focuses on whether Chelsea Therapeutics International and its executives violated federal securities laws by failing to disclose that, Chelsea Therapeutics’ Northera (droxidopa) product, an orally-active synthetic precursor of norepinephrine being developed for the treatment of symptomatic neurogenic orthostatic hypotension, would not receive approval from the U.S. Food and Drug Administration (“FDA”) and Chelsea Therapeutics’ numerous statements regarding the safety and efficacy of the product, as well as reportedly positive results from Northera’s clinical trials, were materially false and misleading.
On February 13, 2012, Chelsea Therapeutics International Ltd announced that it had received a briefing document prepared by FDA staff that revealed results of an Advisory Committee tasked with determining the safety of Northera and the plaintiff says that "the briefing document indicated that the FDA raised questions concerning Northera's risk-benefit analysis."
On February 23, 2012, Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA.
However, then on March 28, 2012, after the market closed, Chelsea Therapeutics International disclosed that it had received a complete response letter from the FDA whereby it rejected the Company's New Drug Application for Northera. Moreover, the FDA requested that the Company "submit data from an additional positive study to support efficacy demonstrated in Study 301 along with the recommendation that such a study be designed to demonstrate durability of effect over a 2- to 3-month period."
Shares of Chelsea Therapeutics International (NASDAQ:CHTP) shares dropped from almost $5 on February 10, 2012 to as low as $0.865 per share on July 3, 2012.
On August 27, 2012, Chelsea Therapeutics International shares closed at $1.00 per share.
Those who purchased shares of Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) between November 3, 2008 and March 28, 2012, have certain options and should contact the Shareholders Foundation.
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