Amicus Therapeutics Inc (NASDAQ: FOLD) Investor Securities Class Action Lawsuit 10/07/2015

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Company Name(s): 
Amicus Therapeutics
Case Name: 
Amicus Therapeutics Shareholder Class Action Lawsuit 10/07/2015
Case Status: 
Lawsuit Filed
Case Status: 
Settlement Proposed
Affected Securities
NASDAQ: FOLD
Lawsuit Overview
Type of Lawsuit: 
Shareholder Class Action
Date Filed: 
10/07/2015
Class Period Begin: 
03/19/2015
Class Period End: 
10/01/2015
Court of Filing: 
U.S. District Court for the District of New Jersey
Deadline To File for Lead: 
12/07/2015
Date Settled: 
06/29/2017
Settlement Amount: 
$3,750,000
Deadline to Participate in Settlement: 
01/01/2018
Summary: 

June 29, 2017 - The court preliminarily approved the settlement.

April 14, 2017 - Parties filed a stipulation of settlement.

August 25, 2016 - Defendants filed a motion to dismiss.

July 11, 2016 - The lead plaintiff filed an amended consolidated complaint.

May 26, 2016 - Lead plaintiff and lead counsel were appointed and all cases were consolidated.

December 7, 2015 - Lead plaintiff motions were filed.

October 13, 2015 - Another investor filed a complaint.

October 8, 2015 - Another investor filed a complaint.

October 7, 2015 - An investor in shares of Amicus Therapeutics Inc (NASDAQ: FOLD) filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by Amicus Therapeutics Inc in connection with certain allegedly false and misleading statements made between March 19, 2015 and October 1, 2015.

According to the complaint the plaintiff alleges on behalf of purchasers of Amicus Therapeutics Inc (NASDAQ: FOLD) common shares between March 19, 2015 and October 1, 2015, that the defendants violated Federal Securities Laws. More specifically, 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 Inc’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.”

The plaintiff claims that defendants allegedly failed to disclose, among other things, that Amicus Therapeutics Inc’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 that as a result, Amicus Therapeutics Inc had no reasonable basis to represent that it would submit its NDA for accelerated approval in the second half of 2015.

Shares of Amicus Therapeutics Inc (NASDAQ: FOLD) grew from $1.84 per share in April 2014 to as high $18.40 per share on September 14, 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.