Glancy Prongay & Murray LLP announces that it is investigating potential claims on behalf of investors of Amicus Therapeutics, Inc. concerning the company’s and its officers’ possible violations of federal securities laws in connection with the company’s recently announced delay in submitting a New Drug Application (NDA) to the FDA.
On October 2, 2015, the company disclosed that the FDA had “requested further integration of existing clinical data across studies” in connection with Amicus’s migalastat monotherapy treatment for Fabry disease, and that, “Amicus does not anticipate being in a position to submit the NDA for migalastat monotherapy in the United States by the end of this year.”
On this news, the company’s stock fell $7.36 (over 53%) to close at $6.39 on October 2, 2015, thereby injuring Amicus investors. News of the delay in the FDA approval process comes shortly after the company completed an offering of securities to the public.