Rigrodsky & Long, P.A. announces that a complaint has been filed in the United States District Court for the Western District of North Carolina, Charlotte Division on behalf of all persons or entities that purchased the securities of Chelsea Therapeutics International, Ltd. (“Chelsea” or the “Company”) (NasdaqCM: CHTP) between June 9, 2011 and February 17, 2012, inclusive (the “Class Period”), alleging violations of the Securities Exchange Act of 1934 against the Company and certain of its officers and directors (the “Complaint”). If you purchased shares of Chelsea during the Class Period, or purchased shares prior to the Class Period and still hold Chelsea stock, and wish to discuss this action or have any questions concerning this notice or your rights or interests, please contact Timothy J. MacFall, Esquire or Scott J. Farrell, Esquire of Rigrodsky & Long, P.A., 825 East Gate Boulevard, Suite 300, Garden City, NY at (888) 969-4242, by e-mail to email@example.com, or at: http://www.rigrodskylong.com/investigations/chelsea-therapeutics-international-ltd-chtp. Chelsea, a Delaware corporation headquartered in Charlotte, North Carolina, is a biopharmaceutical company whose lead investigational drug was Northera (trade name Droxidopa) (“Droxidopa”). Droxidopa was in development for treatment of neurogenic orthostatic hypotension (“NOH”) in people with primary autonomic failure, including Parkinson’s disease. Droxidopa has been approved for use in Japan since 1989, but is marketed at lower doses. The Complaint alleges that throughout the Class Period, defendants made materially false and misleading statements regarding the safety and efficacy of Droxidopa, which was then in Phase III testing. Specifically, the Complaint alleges that despite defendants’ positive statements, they failed to disclose that the safety data base was small in light of red flags concerning the safety of Droxidopa that arose during the open-label phases of the trial, including 18 deaths from sepsis, heart attack, pneumonia, respiratory failure, myocardial infarctions, progression of the underlying disease and hyperextensive crisis. In addition, the Complaint alleges there were nine cases of life-threatening neuroleptic malignant syndrome over a ten-year period in Japan; and there were no durable effects from the drug that lasted more than four weeks, which did not warrant approval by the U.S. Food and Drug Administration (the “FDA”) in light of the safety issues with the drug.
According to the Complaint, on February 13, 2012, defendants disclosed that the FDA had provided Chelsea with a briefing document that the FDA staff prepared for a February 23, 2012 Advisory Committee meeting, which raised concerns about the drug’s risks and limited benefit. On that same day, the price of Chelsea common stock declined $1.88 per share, or more than 37%, to close at $3.11 per share.On February 21, 2012, the FDA publicly released the briefing document that had been provided to the Company. The FDA staff recommended to the FDA Advisory Committee that Droxidopa not be approved for use with people suffering from NOH inasmuch as the drug had not demonstrated durable effectiveness and showed worrisome safety issues in test results and post-marketing cases in Japan. As a result, the price of the Company’s common stock declined $0.71 per share, or 21%, to close at $2.64 per share. According to the Complaint, after the close of the market on March 28, 2012, Chelsea disclosed that it had received a complete response letter from the FDA rejecting the Company’s New Drug Application. In addition, the FDA requested that the Company submit data from an additional positive study to support efficacy shown in Study 301, recommending that such a study be designed to demonstrate durability of effect over a 2 to 3 month period. On this news, the price of Chelsea common stock declined $1.051 per share, or more than 28%, to close at $2.62 per share on March 29, 2012. If you wish to serve as lead plaintiff, you must move the Court no later than June 4, 2012. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the proposed class may move the court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.
While Rigrodsky & Long, P.A. did not file the Complaint in this matter, the firm, with offices in Wilmington, Delaware and Garden City, New York, regularly litigates securities class, derivative and direct actions, shareholder rights litigation and corporate governance litigation, including claims for breach of fiduciary duty and proxy violations in the Delaware Court of Chancery and in state and federal courts throughout the United States.Attorney advertising. Prior results do not guarantee a similar outcome.