NEW YORK, Oct. 08, 2015 (GLOBE NEWSWIRE) -- Wolf Popper LLP has filed a class action lawsuit against Amicus Therapeutics, Inc. (NASDAQ:FOLD), and certain of its officers, in the United States District Court for the District of New Jersey, on behalf of all persons who purchased Amicus common stock on the open market or pursuant to Registration Statement, during the period March 19, 2015 through October 1, 2015, and were damaged thereby. This action alleges claims for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
If you are a member of the Class, you may file a motion no later than December 7, 2015 to be appointed a lead plaintiff. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Investors who purchased Amicus common stock during the Class Period and suffered losses are urged to contact Wolf Popper to discuss their rights.
The Complaint charges that during the Class Period, defendants issued a series of false and misleading statements that misrepresented that Amicus had an “approval pathway” for its lead product candidate Galafold, by which it would submit a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for “accelerated approval” of the drug “in the second half of 2015.” Defendants represented that Amicus’s two Phase III global registration studies of Galafold “have shown that treatment with migalastat has resulted in reductions in disorder substrate, stability of kidney function, reductions in cardiac mass, and improvement in gastrointestinal symptoms.”
Defendants failed to disclose, among other things, that Amicus’s two Phase III studies failed to satisfy the FDA’s concerns over migalastat’s effect on gastrointestinal symptoms; that the FDA required full integration and additional analyses of clinical data from the Phase III studies; and as a result, Amicus had no reasonable basis to represent that it would submit its NDA for accelerated approval in the second half of 2015.
On October 2, 2015, after receiving final FDA minutes from a pre-NDA meeting, Amicus revealed that it would not “submit the NDA for migalastat in the United States by the end of this year.” Specifically, the FDA has requested “additional data on migalastat’s effect on gastrointestinal symptoms in Fabry disease” and “further integration of existing clinical data across studies which will require more time to complete.”
On news of the delay of the NDA submission, Amicus shares declined $7.36 per share, or 53.5% on October 2, 2015.
Wolf Popper has successfully recovered billions of dollars for defrauded investors. The firm’s reputation and expertise have been repeatedly recognized by the courts, which have appointed the firm to major positions in securities litigation. See www.wolfpopper.com
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