Insmed reported third-quarter revenue of $524.4 million, led by continued growth in BRINSUPRI, its treatment for non-cystic fibrosis bronchiectasis. The company raised its 2026 revenue guidance for both BRINSUPRI and ARIKAYCE, and said it has launched BRINSUPRI in Japan.
The update also included regulatory progress for ARIKAYCE and milestones across Insmed’s clinical pipeline, including Phase 3 studies of treprostinil palmitil inhalation powder, or TPIP, in several lung diseases.
Commercial performance and guidance
- Total revenue was $524.4 million in the third quarter.
- BRINSUPRI generated $400.1 million, up 29% from the second quarter, with growth driven by the U.S. launch.
- ARIKAYCE generated $124.4 million, up 9% from the third quarter of 2025, primarily reflecting stronger international sales.
- Insmed raised its 2026 BRINSUPRI revenue guidance to $1.35 billion to $1.4 billion and its ARIKAYCE guidance to $460 million to $470 million. The company said it raised the lower end of the full-year ranges for both products.
Japan launch and ARIKAYCE review
- Japan approved BRINSUPRI in August for adults and children ages 12 and older with non-cystic fibrosis bronchiectasis. Insmed launched the 25 mg tablets there in October. The company describes it as the first and only treatment approved by Japan’s health ministry for the condition.
- The FDA accepted Insmed’s application to expand ARIKAYCE’s use in Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial regimen. The agency granted Priority Review and set January 28, 2027 as its target decision date.
- Insmed plans to submit results from the Phase 3 ENCORE study to Japan’s regulator in the fourth quarter of 2026, seeking support for a potential ARIKAYCE label expansion to all patients with MAC lung disease.
Pipeline progress
- TPIP: Insmed said enrollment in the Phase 3 PALM-ILD study, in pulmonary hypertension associated with interstitial lung disease, has passed 35%; it expects enrollment to finish in the first half of 2028. The company enrolled the first patient in its Phase 3 PAH study in July and began its Phase 3 study in progressive pulmonary fibrosis in September. It still expects to start a Phase 3 study in idiopathic pulmonary fibrosis in the first half of 2027.
- INS1148: The company is advancing a Phase 2 program initially targeting idiopathic pulmonary fibrosis, with plans to evaluate the drug in progressive pulmonary fibrosis and other diseases.
- INS1033: A Phase 1 study of the DPP1 inhibitor, which is being developed for rheumatoid arthritis, began enrolling healthy volunteers in September.
- INS1201: Insmed completed enrollment in a Phase 1 study of its gene therapy for Duchenne muscular dystrophy.
- INS1202: Enrollment continues in a Phase 1 study of its gene therapy for amyotrophic lateral sclerosis.
- Insmed also presented five respiratory-disease research abstracts at the European Respiratory Society Congress in September.
The update shows BRINSUPRI and ARIKAYCE contributing growing commercial revenue, alongside regulatory expansion efforts for both products. Insmed is also advancing TPIP into Phase 3 testing across four lung-disease indications, with studies at different stages of initiation and enrollment.