NEW YORK, April 12, 2012 (GLOBE NEWSWIRE) -- Pomerantz Haudek Grossman & Gross LLP has filed a federal securities class action (3:12-cv-00213) in the United States District Court, Western District of North Carolina, on behalf of all persons who purchased Chelsea Therapeutics International Ltd. ("Chelsea" or the "Company"), (Nasdaq:CHTP), securities between November 3, 2008 and March 28, 2012, inclusive (the "Class Period"). This class action is brought under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder against the Company and certain of its top officials.
If you are a shareholder who purchased Chelsea securities during the Class Period, you have until June 4, 2012 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Rachelle R. Boyle at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll free, x237. Those who inquire by e-mail are encouraged to include their mailing address and telephone number.
Chelsea is a biopharmaceutical company developing a pipeline of low toxicity antifolate compounds engineered to produce anti-inflammatory and anti-tumor effects. The Complaint alleges that throughout the Class Period, 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.
On February 13, 2012, the Company disclosed that the FDA had raised questions regarding the size and duration of its clinical trials for Northera. In addition, FDA investigators noted three deaths as being possibly related to Northera. As a result, Chelsea shares declined $1.88 per share or more than 37.5%, to close at $3.11 per share on February 13, 2012.
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." As a result of this revelation, Chelsea shares declined $0.71 per share or 21%, to close at $2.64 per share on February 21, 2012.
On March 28, 2012, after the market closed, Chelsea 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." As a result of this news, Chelsea shares declined $1.051 per share or more than 28%, to close at $2.62 per share on March 29, 2012.
The Pomerantz Firm, with offices in New York, Chicago, and Washington, D.C., is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 70 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
CONTACT: Rachelle R. Boyle
Pomerantz Haudek Grossman & Gross LLP