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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): July 24, 2020

 

 

INSMED INCORPORATED

(Exact Name of Registrant as Specified in Charter)

 

 

Virginia   000-30739   54-1972729

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

700 US Highway 202/206

Bridgewater, New Jersey 08807

(Address of Principal Executive Offices,and Zip Code)

 

(908) 977-9900

Registrant’s Telephone Number, Including Area Code

 

Not Applicable

(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 (see General Instruction A.2. below):

 

¨      Written communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨      Pre-commencement communication 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 per share   INSM   Nasdaq Global Select Market

 

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 July 24, 2020, Insmed Incorporated issued a press release with respect to the announcement summarized in Item 8.01 below. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

ITEM 8.01 – Other Events.

 

On July 24, 2020, Insmed Incorporated announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the treatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium complex in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

 

ITEM 9.01 - Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.
  Description
99.1   Press release issued by Insmed Incorporated on July 24, 2020.
104   Cover Page Interactive Date File (embedded within the Inline XBRL document).

 

 

 

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.

 

 

Dated: July 24, 2020 INSMED INCORPORATED
     
  By: /s/ Christine Pellizzari
  Name: Christine Pellizzari
  Title: Chief Legal Officer

 

 

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