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FOLD Amicus Therapeutics

Filed: 3 May 21, 7:01am

 

 

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): May 3, 2021

 

AMICUS THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of

Incorporation)

 

Delaware 001-33497 71-0869350

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

3675 Market Street, Philadelphia, PA 19104

(Address of Principal Executive Offices, and Zip Code)

 

215-921-7600

Registrant’s Telephone Number, Including Area Code

 

(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:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

  

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock Par Value $0.01FOLDNASDAQ

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ¨

 

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. ¨

 

 

 

 

 

 

Item 8.01 – Other Events

 

On May 3, 2021, Amicus Therapeutics, Inc. issued a press release announcing the completion of a successful Type B Pre-Biologics License Application (“BLA”) meeting with the U.S. Food and Drug Administration for AT-GAA (cipaglucosidase alfa co-administered with miglustat), its investigational two-component therapy for the treatment of Pompe disease. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits:

 

Exhibit No. Description
99.1 Press Release dated May 3, 2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

Signature Page

 

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.

 

 AMICUS THERAPEUTICS, INC.
  
Date: May 3, 2021By:/s/ Ellen S. Rosenberg
 Name:Ellen S. Rosenberg
 Title:Chief Legal Officer and Corporate Secretary