NEW YORK, Oct. 16, 2015 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a securities class action lawsuit has been commenced against Amicus Therapeutics, Inc. (“Amicus” or “Company”) (NASDAQ:FOLD) 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 the Secondary Public Offering (“SPO”) on June 11, 2015, during the period March 19, 2015 through October 1, 2015, inclusive. Shareholders of Amicus Therapeutics, Inc. who incurred losses on shares purchased within the Class Period are urged to contact the firm immediately at firstname.lastname@example.org or (800) 575-0735 or (212) 545-4774.
If you purchased the shares of Amicus Therapeutics, Inc. during the period from March 19, 2015 through October 1, 2015, inclusive, you may, no later than December 7, 2015, request that the Court appoint you lead plaintiff of the proposed class.
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 Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.
If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein Adler Freeman & Herz LLP by telephone at (800) 575-0735, via e-mail at email@example.com, or visit our website at www.whafh.com. All e-mail correspondence should make reference to the “Amicus Investigation.”
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Contact: Wolf Haldenstein Adler Freeman & Herz LLP Patrick Donovan, Esq. Gregory Stone, Director of Case and Financial Analysis Email: firstname.lastname@example.org, email@example.com or firstname.lastname@example.org Tel: (800) 575-0735 or (212) 545-4774
Source:Wolf Haldenstein Adler Freeman & Herz LLP