INSMED INCORPORATED (NASDAQ:INSM) Files An 8-K Regulation FD DisclosureITEM 7.01 — Regulation FD Disclosure.
On January3, 2018,Insmed Incorporated (the “Company”) issued a press release announcing additional data from its Phase 3 CONVERT and INS-312 studies of ALIS (Amikacin Liposome Inhalation Suspension) in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex and progress with regulatory and pre-commercial activities. The press release is attached hereto as Exhibit99.1 and incorporated herein by reference.
The Company will host a conference call to discuss the additional data from its Phase 3 CONVERT and INS-312 studies on the date hereof at 5:00 PM Eastern Time, and a live webcast of the call will be available through the investor relations section of the Company’s website. The slide presentation to be used by the Company during the call is attached hereto as Exhibit99.2 and incorporated herein by reference.
ITEM 9.01 – Financial Statements and Exhibits.
(d)Exhibits
|
Exhibit No.
|
Description
|
|
99.1
|
Press Release issued by Insmed Incorporated on January3, 2018.
|
|
99.2
|
Insmed Incorporated ALIS Clinical Update Call Presentation, dated January3, 2018.
|
INSMED Inc ExhibitEX-99.1 2 a18-2170_1ex99d1.htm EX-99.1 Exhibit 99.1 Insmed Announces Additional Data from ALIS (Amikacin Liposome Inhalation Suspension) Phase 3 Clinical Program for Adult Patients with Treatment Refractory NTM Lung Disease Caused by MAC and Reports Progress with Commercial Preparations · Interim results from INS-312 show that 28% of patients who previously received 6 months of guideline based therapy (GBT) alone achieved culture conversion following addition of ALIS to therapy,…To view the full exhibit click here
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.