Chelsea Therapeutics International, Ltd. CHTP Securities Stock Fraud

Company:	Chelsea Therapeutics International, Ltd.
Ticker Symbol:	CHTP
Class Period:	Nov-3-08 to Mar-28-12
Date Filed:	May-1-12
Lead Plaintiff Deadline:	Jun-30-12
Court:	Western District of North Carolina
Allegations:

San Diego, CA: A securities class action lawsuit has been commenced in the United States District Court for the Western District of North Carolina on behalf of purchasers of Chelsea Therapeutics International, Ltd. ("Chelsea") common stock during the period between November 3, 2008 and March 28, 2012 (the "Class Period").

The complaint charges Chelsea and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Chelsea is a biopharmaceutical company that has been developing the drug Northera ("Droxidopa") for use in treating neurogenic orthostatic hypotension ("NOH") in patients with primary autonomic failure, including Parkinson's disease.

The complaint alleges that during the Class Period, defendants issued materially false and misleading statements regarding the safety and efficacy of Droxidopa for patients with NOH, the results of the Phase III testing of Droxidopa for patients with NOH, the post-marketing events in Japan (where Droxidopa has been approved for the same indication at lower doses) and the likelihood of FDA approval of Droxidopa for patients with NOH in light of the known adverse material facts concerning Droxidopa for patients with NOH. As a result of defendants' false statements, Chelsea's stock traded at artificially inflated prices during the Class Period, reaching a high of $8.15 per share on January 10, 2011.

On February 13, 2012, defendants announced that the FDA had provided Chelsea with the briefing document that the FDA staff had prepared for the February 23, 2012 Advisory Committee meeting, which raised questions concerning Droxidopa's risk-benefit analysis. On February 21, 2012, the FDA publicly released the briefing document that had been provided to Chelsea on February 13, 2012.

The FDA staff recommended that Droxidopa for patients with NOH not be approved for use in the United States, stating that Droxidopa had not demonstrated durable effectiveness in clinical trials and showed "worrisome" safety signals in test results and in post-marketing cases in Japan, where it has been in use in lower doses.

Then on March 28, 2012, Chelsea received a response letter from the FDA to its new drug application for Droxidopa, requesting that Chelsea submit data from an additional positive study to support the efficacy of Droxidopa and further indicated that additional bioequivalence work would be needed to support the approval of the drug. On this news, Chelsea stock dropped $1.05 per share, to close at $2.62 per share on March 29, 2012, a one-day decline of 29%.

If you acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.

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Published on May-2-12