According to the law firm press release, the lawsuit charges that Amicus and certain of its officers misrepresented when it would be able to file its New Drug Application with the Food and Drug Administration ("FDA") for its NDA for its oral small molecule pharmacological chaperone migalastat for the treatment of Fabry disease. Defendants publicly stated that, based on information provided by the FDA, the NDA was on track for filing in the fourth quarter of 2015.
On October 2, 2015, Amicus revealed that it would no longer be in a position to submit its NDA in the fourth quarter of 2015. Amicus' stock price plunged on this news, falling by 54% to $6.39 per share.
On May 26, 2016, the Court issued an Order appointing lead plaintiff and approving lead counsel.
On April 14, 2017, the parties entered into a Stipulation of Settlement.