Insmed, Inc. (INSM) announced that the FDA has accepted a regulatory filing for label expansion of its drug Arikayce, aimed at treating mycobacterium avium complex (MAC) lung disease. The FDA granted a priority review, with a final decision anticipated by January 28, 2027, which will fast-track review by four months.
This filing seeks approval for Arikayce as part of a combination antibacterial regimen for newly diagnosed MAC lung disease patients, building on previous approvals in 2018 for refractory MAC lung disease. The application is supported by the phase IIIb ENCORE study, which demonstrated significant improvement in respiratory symptoms.
Insmed estimates the total addressable market for refractory MAC lung disease at around 30,000 patients in the U.S., Europe, and Japan, with the potential broader market exceeding 200,000 patients. In 2026, Arikayce generated $214.4 million in sales during the first half, with projections for full-year sales between $450 million and $470 million.
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