Chelsea Therapeutics International, Ltd.
Class Period: Jun 9, 2011 to Feb 17, 2012
Lead Plaintiff Deadline: Jun 4, 2012 + Deadline passed
Summary of Case:
A securities class action has been filed against Chelsea Therapeutics International, Ltd. ("Chelsea" or the Company") on behalf of all those who purchased or otherwise acquired Chelsea between June 9, 2011 and February 17, 2012. The case was filed in the USDC - North Carolina (Western).
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.
If you purchased this company's shares during the Class Period and suffered a loss or for further information about the case, please review the links below.