Insmed Inc (NASDAQ:INSM) on Friday outlined a commercial and clinical roadmap for 2026, highlighting strong momentum from its respiratory portfolio and a series of upcoming trial readouts and launches that could shape the company’s growth over the next 18 months.
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Speaking ahead of Insmed’s presentation at the J.P. Morgan Healthcare Conference, Will Lewis, chair and CEO, said 2025 marked a turning point for the company as it translated scientific advances into commercial execution.
Insmed reported preliminary Brinsupri revenues of $172.7 million for full-year 2025 and approximately $144.6 million for the first full quarter of launch after FDA approval in August 2025.
Brinsupri (brensocatib) is a prescription medicine used to treat non-cystic fibrosis bronchiectasis in patients 12 years of age and older.
By year-end, roughly 4,000 medical professionals had prescribed the therapy, with about 9,000 new patients initiating treatment in the fourth quarter alone.
Brinsupri received European Commission approval in November 2025 for non-cystic fibrosis bronchiectasis in patients aged 12 and older.
Insmed plans to launch the drug in the European Union in the first half of 2026 and anticipates additional launches in the U.K. and Japan, pending regulatory clearance.
Arikayce remains a key revenue driver, with Insmed forecasting 2026 global sales between $450 million and $470 million. The company expects Arikayce sales to exceed the upper end of 2025 guidance, with preliminary sales of approximately $433.8 million.
Upcoming Catalysts
The company expects topline results from the Phase 3 ENCORE trial of Arikayce in newly diagnosed or recurrent mycobacterium avium complex lung disease patients by March or April 2026.
If successful, Insmed plans to submit a supplemental NDA to the FDA in the second half of the year to broaden Arikayce’s U.S. label.
The pipeline also includes treprostinil palmitil inhalation powder (TPIP), with multiple late-stage studies planned or underway.
Insmed initiated a Phase 3 trial in PH-ILD in late 2025 and plans to start a Phase 3 PAH study in early 2026, with additional fibrosis studies expected later in the year.
Insmed is advancing brensocatib in hidradenitis suppurativa, with Phase 2b CEDAR study data expected in the second quarter of 2026, and preparing INS1033 for an IND filing in inflammatory diseases.
The company’s neuro pipeline includes the Phase 1 ASCEND trial of an intrathecal gene therapy for Duchenne muscular dystrophy, the Phase 1 ARMOR study of INS1202 for amyotrophic lateral sclerosis, and a preclinical Stargardt disease trial, with an IND filing planned for 2026.
Insmed said its preclinical engine includes more than 30 programs, with expectations to file one to two INDs annually while keeping preclinical spending below 20% of total expenditures.
In December 2025, Insmed said the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.
INSM Price Action: Insmed stock is up 2.92% at $175.24 at publication on Friday.
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