Insmed Inc (NASDAQ: INSM) has announced a detailed strategic blueprint for 2026, aiming to build upon positive commercial momentum in its respiratory disease treatments and advance multiple clinical programs with data readouts anticipated over the next 18 months. The company highlighted its plans during a presentation ahead of the J.P. Morgan Healthcare Conference, underscoring the transition from scientific innovation to commercial execution marked in 2025.
Chair and CEO Will Lewis noted that 2025 was a pivotal year as Insmed translated significant scientific achievements into operational progress. Preliminary revenue reports for Brinsupri (brensocatib), approved by the FDA in August 2025 for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older, indicated sales of $172.7 million for the full year. Additionally, the product generated approximately $144.6 million in its first full quarter post-launch.
Brinsupri's commercial uptake is evidenced by approximately 4,000 prescribing healthcare professionals by the end of 2025, and about 9,000 new patients beginning treatment during the fourth quarter alone. The drug secured European Commission approval in November 2025 for the same NCFB indication in patients aged 12 and above, with plans for a European Union launch in the first half of 2026. Insmed also anticipates launching Brinsupri in the United Kingdom and Japan upon receiving respective regulatory clearances.
Meanwhile, Arikayce remains a key revenue generator for Insmed. The company forecasts global sales between $450 million and $470 million in 2026, expecting to surpass the upper guidance of approximately $433.8 million in preliminary sales for 2025. This denotes a sustained contribution to Insmed's commercial portfolio from its existing respiratory therapies.
Looking forward, the company anticipates topline results from the Phase 3 ENCORE trial evaluating Arikayce in patients newly diagnosed or with recurrent mycobacterium avium complex (MAC) lung disease by March or April 2026. Success in this study would form the basis for a supplemental new drug application to the U.S. Food and Drug Administration in the latter half of 2026, potentially expanding Arikayce's U.S. label.
Insmed's pipeline reflects diversification with drug candidates beyond the respiratory domain. The investigational treprostinil palmitil inhalation powder (TPIP) is under evaluation in multiple late-stage studies. A Phase 3 trial for PH-ILD (pulmonary hypertension associated with interstitial lung disease) commenced in late 2025, and the company plans to initiate a Phase 3 study in pulmonary arterial hypertension (PAH) in early 2026. Additional studies targeting fibrotic lung conditions are expected to start later that year.
Insmed is advancing brensocatib in hidradenitis suppurativa, with pivotal Phase 2b CEDAR trial data anticipated in the second quarter of 2026. Concurrently, it is preparing an investigational new drug (IND) application filing for INS1033, aimed at treating inflammatory diseases.
The company’s neurodegenerative disease treatment pipeline also includes multiple early-stage programs. A Phase 1 ASCEND trial is ongoing for an intrathecal gene therapy targeting Duchenne muscular dystrophy. The Phase 1 ARMOR study is evaluating INS1202 for amyotrophic lateral sclerosis, and there is a preclinical trial focusing on Stargardt disease with plans to submit an IND in 2026.
Insmed stated its preclinical research pipeline supports more than 30 programs. The company expects to file between one and two INDs annually, aiming to maintain preclinical expenditures below 20% of total spending to balance innovation with fiscal discipline.
In a notable setback, the Phase 2b BiRCh study assessing brensocatib in patients with chronic rhinosinusitis without nasal polyps did not achieve the primary or secondary efficacy endpoints for either the 10 mg or 40 mg doses in December 2025.
Shares of Insmed rose by 2.92%, trading at $175.24 at the close on the announcement day, reflecting positive investor response to the company's ambitious clinical and commercial roadmap.