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Form 8-K AMICUS THERAPEUTICS, For: Oct 28

October 28, 2022 5:18 PM EDT
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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): October 28, 2022

 

AMICUS THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

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 class   Trading Symbol(s)  

Name of each exchange on which
registered

Common Stock Par Value $0.01   FOLD   NASDAQ

 

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 7.01 – Regulation FD Disclosure.

 

On October 28, 2022, Amicus Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for cipaglucosidase alfa, the biologic component of AT-GAA. Due to restrictions on travel related to COVID 19, the FDA was unable to conduct the required inspection of the WuXi Biologics manufacturing site in China during the review cycle. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Act, or otherwise subject to the liabilities of that Section. The information in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Act.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits:

 

Exhibit No. Description
99.1 Press Release dated October 28, 2022
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: October 28, 2022 By:  /s/ Ellen S. Rosenberg
  Name: Ellen S. Rosenberg
  Title: Chief Legal Officer and Corporate Secretary

 

 

 

ATTACHMENTS / EXHIBITS

EXHIBIT 99.1

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XBRL TAXONOMY EXTENSION LABEL LINKBASE

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

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IDEA: Financial_Report.xlsx

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