Insmed Reports Strong 2025 Results, FDA Grants Orphan Drug Status to Treprostinil Palmitil
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
Insmed Incorporated reported total company revenues of $606.4 million for full-year 2025 and announced that the FDA granted orphan drug designation to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension. The company ended 2025 with approximately $1.4 billion of cash, cash equivalents, and marketable securities.
BRINSUPRI total revenues reached $144.6 million for the fourth quarter and $172.7 million for full-year 2025. The company anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion. In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom and Japan in 2026.
ARIKAYCE total revenues were $119.2 million for the fourth quarter and $433.8 million for full-year 2025, representing 19% annual growth and exceeding the upper end of full-year 2025 guidance. ARIKAYCE global revenue grew 19% in 2025 compared to 2024, reflecting year-over-year growth across all geographic regions and exceeding the upper end of 2025 guidance of $420 to $430 million. Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.
In March or April of 2026, the company anticipates the topline readout of the Phase 3 ENCORE trial in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics. Pending positive topline data from the ENCORE trial, Insmed plans to submit a supplementary new drug application to the FDA for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency in the second half of 2026 to support potential label expansion in Japan.
In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension. Insmed plans to initiate a Phase 3 study of TPIP (treprostinil palmitil inhalation powder) in patients with PAH in the first half of 2026. Insmed is actively enrolling patients in the PALM-ILD trial, a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease. In January 2026, Insmed presented four abstracts from across its TPIP program at the Pulmonary Vascular Research Institute 2026 congress in Dublin.
The company expects to report data from the open-label extension of its Phase 2b study of TPIP in PAH in the second half of 2026. The company anticipates initiating additional Phase 3 studies of TPIP in patients with progressive pulmonary fibrosis and idiopathic pulmonary fibrosis in the second half of 2026.
In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248). The company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease and moderate to severe asthma.
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa. Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026.
Insmed's second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis and inflammatory bowel disease, with an initial IND filing expected in 2026.
Insmed continues to enroll the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy. In January 2026, the company dosed the first patient in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis. Insmed's third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.