Block & Leviton LLP Investigates Amicus Therapeutics After Announcement That It Will Not File A New Drug Application This Year As Originally Announced

BOSTON, Oct. 2, 2015 /PRNewswire/ -- Shares in Amicus Therapeutics ("Amicus" or the "Company") (NASDAQ: FOLD) have plunged approximately 50% after the company announced that it would no longer be in a position to submit a New Drug Application (or "NDA") for its oral small molecule pharmacological chaperone migalastat for the treatment of Fabry disease by the end of this year.

Just a few weeks prior to today's announcement, on September 15, 2015, the Company stated that it "remain[ed] on track to submit an NDA in the fourth quarter of 2015 under Accelerated Approval."  The September 15 announcement reflected feedback from a "Pre-NDA meeting" with the Food and Drug Administration.

Yet today, approximately two weeks after this upbeat announcement, the Company has concluded that it is "does not anticipate being in a position to submit the NDA for migalastat monotherapy in the United States by the end of this year," and is "further evaluating several U.S. pathways including potentially generating additional data on migalastat's effect on gastrointestinal symptoms in Fabry disease."

Block & Leviton LLP is investigating the Company and certain of its officers and directors to learn the facts behind the company's September 15, 2015 announcement and to determine whether any insiders at the Company personally profited from the alleged misstatements.

If you purchased Amicus stock between September 15, 2015 and October 2, 2015 and have questions about your legal rights, or if you have information relevant to this investigation, please contact attorney Steven Harte of Block & Leviton LLP at (617) 398-5600 or at [email protected].  Confidentiality for any whistleblowers or other persons with information relevant to the investigation is assured.

Block & Leviton is a Boston-based law firm representing investors for violations of securities laws as well as whistleblowing employees who provide information about their employers' violations of law.  The firm's lawyers have collectively been prosecuting securities cases on behalf of investors for over 70 years.

This notice may constitute attorney advertising. 

Contact:         
BLOCK & LEVITON LLP
Steven Harte
(617) 398-5600
[email protected]

SOURCE Block & Leviton LLP

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