Insmed rises on FDA priority review for lung disease drug

By Reuters News

** Shares of drugmaker Insmed INSM.O rise 2% to $122.41 premarket

** Co says US FDA grants priority review to its application seeking full approval of its drug, Arikayce, for Mycobacterium avium complex (MAC) lung disease, a rare infection that can permanently damage the lungs

** Full approval could expand the drug's use to newly diagnosed patients and those with recurring infections; it currently has accelerated approval for patients who have not responded to standard treatment

** FDA sets January 28, 2027, as target date for its decision

** Application is backed by a late-stage study in which Arikayce, when added to other medicines, improved respiratory symptoms and helped clear the infection compared with standard treatment alone

** As of last close, INSM down 31.1% YTD

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