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INSM > SEC Filings for INSM > Form 8-K on 1-Jul-2013All Recent SEC Filings

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Form 8-K for INSMED INC


Other Events, Financial Statements and Exhibits

Item 8.01. Other Events.

On July 1, 2013, Insmed Incorporated (the "Company"), a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, issued a press release announcing top-line results from its Phase 3 clinical trial in the European and Canada of ARIKACEŽ (liposomal amikcain for inhalation), for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infections. In the press release, the Company also announced that the U.S. Food and Drug Administration (the "FDA") has designated ARIKACE as a Qualified Infectious Disease Product (QIDP) for the treatment of Non-Tuberculous Mycobacteria ("NTM") lung infections, and that the FDA has granted ARIKACE fast track designation for the NTM indication. Copies of the press release and supplemental slides being used by the Company in connection with a conference call to discuss the results of the Phase 3 clinical trial are attached as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits

The following exhibits to this report shall be deemed filed under the Securities Exchange Act of 1934, as amended.

Exhibit Number                  Description
99.1             Press Release dated July 1, 2013
99.2             Conference Call Slides dated July 1, 2013

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