Insmed's Arikayce Achieves Phase 3 Success in MAC Lung Disease, Paving Way for Label Expansion and Potential Blockbuster Status

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Insmed's Phase 3b ENCORE (ARISE) study confirmed Arikayce's efficacy in newly diagnosed MAC lung disease patients, achieving 78.8% culture conversion vs. 47.1% with standard therapy.123

Insmed plans to file a supplemental new drug application (sNDA) for Arikayce's MAC label expansion in H2 2026.134

Arikayce generated $433.8 million in 2025 revenue; 2026 guidance projects $450-470 million, a 4-6% increase.1

Market reaction to results was muted, with investor focus shifting to Brensocatib's potential $1B+ revenue in 2026, overshadowing Arikayce's growth.1

Arikayce previously received accelerated approval in 2018 for refractory MAC lung disease.2

Sources:

1. https://www.ainvest.com/news/insmed-arikayce-mac-label-expansion-confirmation-catalyst-brensocatib-steals-growth-narrative-2603/

2. https://www.statnews.com/2026/03/23/insmed-mac-lung-infection-arikayce-results/

3. https://investor.insmed.com/2026-03-23-Insmed-Announces-Positive-Topline-Results-from-Phase-3b-ENCORE-Study-of-ARIKAYCE-R-Amikacin-Liposome-Inhalation-Suspension-in-Patients-with-MAC-Lung-Disease

4. https://insights.citeline.com/scrip/therapeutic-category/antiparasitic/insmed-has-big-arikayce-label-expansion-in-its-sights-HQKW6HSOIBH2BNPCT4WMUMBQVA/