December 5, 2016 (Shareholders Foundation) - An investigation on behalf of investors in shares of Amicus Therapeutics, Inc. (NASDAQ:FOLD) was announced over potential breaches of fiduciary duties by certain directors at Amicus Therapeutics.

The investigation by a law firm concerns whether certain Amicus Therapeutics directors breached their fiduciary duties and caused damage to the company and its shareholders.

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.


On October 8, 2015, a lawsuit was filed against Amicus Therapeutics, Inc over alleged Securities Laws Violations. The plaintiff claimed that the 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 claimed that Defendants allegedly failed to disclose, among other things, that Amicus Therapeutics two Phase III studies failed to satisfy the FDAs concerns over migalastats 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 November 28, 2016 Amicus Therapeutics, Inc announced its planned regulatory pathway to collect additional data to support full approval for the oral precision medicine migalastat for Fabry disease.

According to the investigation Amicus Therapeutics, Inc is now facing an extended delay of potential two years or more years before a U.S. approval filing for the Fabry disease drug Galafold will be ready.

Shares of Amicus Therapeutics, Inc. (NASDAQ:FOLD) declined to as low as $5.74 per share on December 1, 2016.

On December 5, 2016, NASDAQ:FOLD shares closed at $5.99 per share.