A lawsuit was filed on behalf of investors in Amicus Therapeutics, Inc. (NASDAQ:FOLD) shares over alleged securities laws violations and NASDAQ:FOLD investors should contact the Shareholders Foundation.
San Diego, CA -- (SBWIRE) -- 10/27/2015 -- A shareholder, who purchased shares of Amicus Therapeutics, Inc. (NASDAQ:FOLD), filed a lawsuit against Amicus Therapeutics, Inc. in New Jersey over alleged violations of Securities Laws in connection with certain allegedly false and misleading statements.
Investors who purchased shares of Amicus Therapeutics, Inc. (NASDAQ:FOLD) have certain options and for certain investors are short and strict deadlines running. Deadline: December 7, 2015. NASDAQ:FOLD investors should contact the Shareholders Foundation at mail@shareholdersfoundation or call +1(858) 779 - 1554.
The plaintiff claims that between March 19, 2015 and October 1, 2015 defendants issued a series of allegedly false and misleading statements that misrepresented that Amicus Therapeutics, Inc. 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 and that Defendants represented that Amicus Therapeutics' 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."
The plaintiff claims that Defendants allegedly failed to disclose, among other things, that Amicus Therapeutics' 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 that as a result, Amicus Therapeutics 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, Amicus Therapeutics, Inc announced that after meeting with FDA officials earlier in the week, the company does not anticipate being in a position to submit a new drug application (NDA) for migalastat, the company's Fabry disease treatment, by the end of the year. The FDA has requested further integration of existing clinical data across studies, which will require more time to complete.
Shares of Amicus Therapeutics, Inc. (NASDAQ:FOLD) declined from $13.75 per share on October 1, 2015 to as low as $5.69 per share on October 2, 2015.
Those who purchased shares of Amicus Therapeutics, Inc. have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com