INSMED INCORPORATED (NASDAQ:INSM) Files An 8-K Regulation FD DisclosureITEM 7.01 – Regulation FD Disclosure.
On May16, 2018,Insmed Incorporated issued a press release announcing that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with Nontuberculous Mycobacterial lung disease caused by Mycobacterium avium complex, and that the application will be considered filed on May 27, 2018. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
ITEM 9.01 – Financial Statements and Exhibits.
INSMED Inc ExhibitEX-99.1 2 a18-13637_1ex99d1.htm EX-99.1 Exhibit 99.1 Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC · PDUFA Action Date Set for September 28,…To view the full exhibit click
About INSMED INCORPORATED (NASDAQ:INSM)
Insmed Incorporated is a biopharmaceutical company. The Company operates in the segment of development and commercialization of inhaled therapies for patients with serious lung diseases. The Company’s lead product candidate, ARIKAYCE, or liposomal amikacin for inhalation (LAI), which is in late-stage development for patients with nontuberculous mycobacteria (NTM) lung disease, a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. The Company’s earlier stage pipeline includes INS1009, a nebulized prodrug formulation of treprostinil, a vasodilator of pulmonary arterial vascular beds. The Company is conducting a global Phase III clinical study of ARIKAYCE (the 212 or CONVERT study) in adult patients with NTM lung disease caused by Mycobacterium avium complex (MAC), the infective species in NTM lung disease in the United States, Europe and Japan.
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