Insmed Reports Strong BRINSUPRI Launch with $144.6M First Quarter Revenue, Advances Multiple Phase 3 Programs
核心洞察
Insmed's BRINSUPRI (搜索) achieved approximately $144.6 million in unaudited revenues for its first full quarter of launch, with approximately 4,000 medical professionals prescribing the therapy.
ARIKAYCE exceeded guidance with approximately $433.8 million in global revenues for 2025, with 2026 revenues projected between $450-470 million.
The company initiated Phase 3 PALM-ILD study for TPIP (搜索) in pulmonary hypertension (搜索) and plans additional Phase 3 studies across multiple indications in 2026.
Insmed Incorporated reported robust commercial performance and outlined an ambitious clinical development roadmap during its business update at the 44th Annual J.P. Morgan Healthcare Conference, highlighting the successful launch of BRINSUPRI (搜索) and continued growth of ARIKAYCE.
Strong Commercial Performance Across Portfolio
BRINSUPRI (搜索) (brensocatib) demonstrated exceptional uptake in its first full quarter of commercial availability, generating approximately $144.6 million in unaudited total revenues. The therapy achieved full-year 2025 revenues of approximately $172.7 million, with approximately 4,000 medical professionals prescribing BRINSUPRI and approximately 9,000 new patients starting therapy during the fourth quarter of 2025 alone.
ARIKAYCE (amikacin liposome inhalation suspension (搜索)) exceeded the upper end of guidance for 2025, achieving approximately $433.8 million in unaudited global revenues. The company projects 2026 global ARIKAYCE revenues to be between $450 million and $470 million.
"2025 was a landmark year for the patients we serve, our company, and our people, during which we demonstrated what's possible when breakthrough science meets steadfast execution," said Will Lewis, Chair and Chief Executive Officer of Insmed.
Expanding Phase 3 Development Programs
TPIP Advances Across Multiple Indications
Insmed initiated PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP (搜索)) in patients with pulmonary hypertension (搜索) associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025. The company plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (搜索) (PAH) in early 2026.
Additional Phase 3 studies of TPIP (搜索) in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) are anticipated in the second half of 2026. 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.
ARIKAYCE Expansion Strategy
The Phase 3 ENCORE trial, evaluating ARIKAYCE in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics, is expected to report topline data in March or April of 2026. Pending successful results, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (搜索) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026.
Pipeline Expansion and New Acquisitions
Novel Monoclonal Antibody Platform
In December 2025, Insmed acquired INS1148 (搜索), a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor 248 (搜索) (SCF248 (搜索)). The company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease and moderate-to-severe asthma. Through its novel mechanism of action, INS1148 has the potential to preferentially target SCF248, which prevents only the inflammatory cascade downstream of c-Kit (搜索) signaling, while leaving critical homeostatic and tissue healing pathways intact.
Gene Therapy Advancement
Insmed is currently enrolling cohorts 2 and 3 in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (搜索) (DMD). In December 2025, the company opened the first clinical site for the Phase 1 ARMOR study of INS1202 (搜索), an intrathecally-delivered gene therapy for patients with Amyotrophic Lateral Sclerosis (搜索) (ALS).
Immunology and Inflammation Programs
Brensocatib Development Beyond NCFB
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (搜索) (HS). The company anticipates reporting topline data from CEDAR in the second quarter of 2026.
Insmed's second dipeptidyl peptidase 1 (搜索) (DPP1 (搜索)) inhibitor, INS1033 (搜索), is currently advancing toward the clinic in rheumatoid arthritis (搜索) (RA) and inflammatory bowel disease (搜索) (IBD), with an IND filing expected in 2026.
European Expansion Plans
In November 2025, the European Commission approved BRINSUPRI (搜索) (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (搜索) (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Insmed plans to launch BRINSUPRI in the European Union in the first half of 2026 and anticipates commercial launches in the United Kingdom and Japan in 2026, pending approval in each territory.
Robust Pre-Clinical Pipeline
Insmed's research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued. The company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs, with the totality of pre-clinical research programs comprising less than 20% of overall expenditures.
The company's third gene therapy candidate, INS1203 (搜索), targeting Stargardt disease (搜索), is currently advancing toward the clinic, with an IND filing expected in 2026.