AMICUS THERAPEUTICS, INC.

Regulatory Filings • Jun 28, 2017

8-K 1 a17-15821_18k.htm 8-K

*UNITED STATES*

*SECURITIES AND EXCHANGE COMMISSION*

*WASHINGTON, D.C. 20549*

*FORM 8-K*

*CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934*

Date of Report (Date of earliest event reported): *June 28* , 2017

*AMICUS THERAPEUTICS, INC.*

(Exact Name of Registrant as Specified in Its Charter)

*Delaware*

(State or Other Jurisdiction of Incorporation)

001-33497	71-0869350
(Commission File Number)	(IRS Employer Identification No.)

1 Cedar Brook Drive, Cranbury, NJ	08512
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (609) 662-2000

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

SEQ.=1,FOLIO='',FILE='C:\JMS\109769\17-15821-1\task8484833\15821-1-ba.htm',USER='109769',CD='Jun 28 01:47 2017'

*Item 8.01. Other Events.*

On June 28, 2017, Amicus Therapeutics, Inc. (the “Company”) issued a press release announcing that the Company submitted a Japanese new drug application to the Pharmaceuticals and Medical Devices Agency to request marketing authorization for migalastat. A copy of this press release is attached hereto as Exhibit 99.1.

*Item 9.01. Financial Statements and Exhibits.*

(d) Exhibits: The Exhibit Index annexed hereto is incorporated herein by reference.

Exhibit No.	Description
99.1	Press Release dated June 28, 2017 titled “Amicus Therapeutics Submits Japanese New Drug Application for Migalastat for Fabry Disease.”

2

SEQ.=1,FOLIO='2',FILE='C:\JMS\109769\17-15821-1\task8484833\15821-1-ba.htm',USER='109769',CD='Jun 28 01:47 2017'

*SIGNATURES*

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

/s/ ELLEN S. ROSENBERG
Ellen S. Rosenberg
General Counsel and Corporate Secretary

3

SEQ.=1,FOLIO='3',FILE='C:\JMS\109769\17-15821-1\task8484833\15821-1-ba.htm',USER='109769',CD='Jun 28 01:47 2017'

*EXHIBIT INDEX*

Exhibit No.	Description
99.1	Press Release dated June 28, 2017 titled “Amicus Therapeutics Submits Japanese New Drug Application for Migalastat for Fabry Disease.”

4

SEQ.=1,FOLIO='4',FILE='C:\JMS\109769\17-15821-1\task8484833\15821-1-ba.htm',USER='109769',CD='Jun 28 01:47 2017'