Insmed Reports Positive Topline Results from Phase 3b ENCORE Study of ARIKAYCE in MAC Lung Disease

INSMED Inc

Primary endpoint met: change from baseline in Respiratory Symptom Score at Month 13 showed 17.77 vs 14.66 points (p=0.0299).
All multiplicity-controlled secondary culture conversion endpoints met: 87.8% vs 57.0% by Month 6, 84.7% vs 61.3% by Month 12 (p<0.0001).
Durable culture conversion at Month 15: 76.2% vs 47.6% (p<0.0001).
Plans to file sNDA in U.S. and submit data to PMDA in Japan in H2 2026 for potential label expansion.
Safety profile consistent with known ARIKAYCE profile; no new safety signals observed.

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