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Insmed Incorporated Message Board

ries123 1 post  |  Last Activity: Dec 15, 2014 7:03 AM Member since: Jun 26, 2013
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  • Insmed has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and is awaiting its validation.

    Insmed's phase 3 pivotal trial for patients with treatment resistant nontuberculous mycobacteria (NTM) lung infections (the "212" trial) is on track.

    Insmed has completed a pre-investigational new drug (IND) meeting with the FDA for INS-1009, its novel formulation of a proven prostacyclin therapy for the treatment of Pulmonary Arterial Hypertension (PAH) and has clarified that, subject to final review of the pre-clinical data, it would be eligible for a 505(b)(2) approval pathway.

    Sentiment: Strong Buy

15.80-0.16(-1.00%)11:26 AMEST

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