Insmed shares up on FDA priority review for lung disease drug
Insmed Inc shares rose 2% premarket to $122.41 after the U.S. Food and Drug Administration granted priority review for its Arikayce drug to treat Mycobacterium avium complex lung disease. Full approval could expand its use to newly diagnosed patients. The FDA set a target decision date of Jan. 28, 2027. A late-stage study showed Arikayce improved symptoms and helped clear the infection when added to other treatments compared to standard therapy alone.
41 in premarket trading after the company said the US FDA granted priority review to its application seeking full approval of Arikayce for Mycobacterium avium complex (MAC) lung disease, a rare infection that can permanently damage the lungs. The company said full approval could expand use of the drug to newly diagnosed patients and those with recurring infections. Arikayce currently has accelerated approval for patients who have not responded to standard treatment. The FDA set January 28, 2027, as the target date for its decision.
The application is supported 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. 1% year to date.