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 17, 2014

 

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

 

Virginia

 

0-30739

 

54-1972729

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification
No.)

 

9 Deer Park Drive, Suite C,

Monmouth Junction, New Jersey

 

 

08852

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (732) 997-4600

 

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):

 

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))

 

 

 


 

Item 8.01.  Other Events.

 

Insmed Incorporated (the “Company”) announced today that the U.S. Food and Drug Administration (the “FDA”) granted ARIKAYCE™, or liposomal amikacin for inhalation, Breakthrough Therapy Designation for the treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease who are treatment refractory.  This designation is based on findings from the Company’s U.S. phase 2 clinical trial of ARIKAYCE to treat NTM lung infections.  The Company has plans to meet with the FDA to discuss the regulatory pathway for ARIKAYCE.

 

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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: June 17, 2014

 

INSMED INCORPORATED

 

 

 

 

 

 

By:

/s/ Christine Pellizzari

 

 

Name:

Christine Pellizzari

 

 

Title:

General Counsel and Corporate Secretary

 

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