San Diego, CA -- (SBWIRE) -- 04/09/2012 -- An investor in NASDAQ:CHTP shares filed a lawsuit in the U.S. District Court for the Western District of North Carolina against Chelsea Therapeutics International Ltd. over alleged Violations of Federal Securities Laws l in connection with certain financial statements.
Investors who purchased shares of Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) between November 3, 2008 and March 28, 2012, have certain options and there are strict and short deadlines running. Deadline: June 4, 2012. NASDAQ:CHTP stockholders should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554..
According to the complaint the plaintiff alleges on behalf of all persons who purchased Chelsea Therapeutics International Ltd. (Nasdaq:CHTP) securities between November 3, 2008 and March 28, 2012, that Chelsea Therapeutics International Ltd. and certain of its top officials violated the Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.
Specifically, the plaintiff claims that between November 3, 2008 and March 28, 2012 defendants conditioned investors to believe that Northera (droxidopa), an orally-active synthetic precursor of norepinephrine being developed for the treatment of symptomatic neurogenic orthostatic hypotension would receive approval from the U.S. Food and Drug Administration ("FDA") through a host of materially false and misleading statements regarding the safety and efficacy of the product, as well as reportedly positive results from Northera's clinical trials.
Then on February 13, 2012, Chelsea Therapeutics International, Ltd issued a press release stating, in part, that it had received the U.S. Food and Drug Administration (“FDA”) briefing document in advance of the upcoming Cardiovascular and Renal Drugs Advisory Committee meeting scheduled for February 23, 2012. Chelsea Therapeutics International further stated that it was updating shareholders on several lines of inquiry that have emerged as significant components of the benefit-risk analysis by the FDA, including “the short duration of [Chelsea Therapeutics’] clinical studies, the limited size of [Chelsea Therapeutics’] study population given the orphan indication and the challenges in quantifying symptomatic and clinical benefit.”
On February 21, 2012, the FDA published information ahead of a meeting by the Cardiovascular and Renal Drugs Advisory Committee of the FDA scheduled for February 23, 2012. The FDA staff report recommended that Northera not be approved "[o]n the basis of the safety concerns compounded by absence of evidence of durability of effect." The FDA staff report concluded that Northera was not approvable as the "durability of effect of droxidopa has not been demonstrated" and "the safety data base was small considering the worrisome safety signals that arose during the open-label phase of the trials which included deaths, strokes, myocardial infarction, progression of underlying disease and hypertensive crisis."
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."
NASDAQ:CHTP shares dropped from almost $5 on February 10, 2012 to under $2.50 in the end of March 2012 and closed on April 5, 2012 at $2.16 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 there are strict and short deadlines running. Deadline: June 4, 2012. NASDAQ:CHTP stockholders should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
3111 Camino Del Rio North - Suite 423
92108 San Diego