Insmed Incorporated reported FY 2025 results with $606.4 million in product revenues, primarily from ARIKAYCE and BRINSUPRI.
Revenue breakdown: ARIKAYCE (62.1%), License And Service (28.2%), BRINSUPRI (9.7%).
8-K
Insmed Incorporated announced positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE plus azithromycin and ethambutol versus placebo plus the same multidrug therapy in 425 patients with newly diagnosed Mycobacterium avium complex lung infection, meeting the primary endpoint of change from baseline in Respiratory Symptom Score at Month 13 (17.77 vs 14.66 points, p=0.0299) and all multiplicity-controlled secondary culture conversion endpoints. The company plans supplemental NDA filing with FDA and data submission to PMDA in second half of 2026 for potential label expansion.