Insmed rises on FDA priority review for lung disease drug
INSM•FDA grants priority review for Arikayce full approval bid
** Shares of drugmaker Insmed INSM.O rise 2% to $122.41 premarket
** Co says U.S. 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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