Insmed Incorporated reported strong second-quarter 2025 financial results, with ARIKAYCE revenue reaching $107.4 million, reflecting 19% growth over the second quarter of 2024. The global biopharmaceutical company continues to advance its pipeline of respiratory therapies while preparing for the anticipated FDA approval of brensocatib for bronchiectasis treatment.
ARIKAYCE Maintains Strong Commercial Performance
ARIKAYCE (amikacin liposome inhalation suspension) demonstrated consistent growth across all geographic regions, contributing to the company's robust quarterly performance. The inhaled antibiotic, approved for treating refractory Mycobacterium avium complex (MAC) lung disease, continues to gain traction in the U.S., Europe, and Japan markets.
The company anticipates topline readout from the Phase 3 ENCORE trial in the first half of 2026, evaluating ARIKAYCE in patients with newly diagnosed or recurrent MAC lung disease who have not started antibiotics. Successful results could support a supplementary new drug application (sNDA) to expand the indication to all patients with MAC lung disease in the second half of 2026.
Brensocatib Approval Decision Imminent
Insmed's brensocatib, a small molecule oral inhibitor of dipeptidyl peptidase 1 (DPP1), remains on track for FDA approval with a PDUFA target action date of August 12, 2025. The FDA granted Priority Review designation to the NDA for bronchiectasis treatment in February 2025.
"Insmed is now 'three for three' in terms of positive clinical trial results for our late-stage assets," said Will Lewis, Chair and Chief Executive Officer. The company has prepared for immediate U.S. launch upon approval and anticipates commercial launches in Europe and the UK in 2026, pending regulatory approval.
Beyond bronchiectasis, brensocatib continues advancing through clinical development for additional indications. The company expects topline data from the Phase 2b BiRCh study in chronic rhinosinusitis without nasal polyps (CRSsNP) by the end of 2025. Patient enrollment continues in the Phase 2b CEDAR study for hidradenitis suppurativa (HS), with interim futility analysis anticipated in the first quarter of 2026.
TPIP Program Advances Following Positive PAH Results
The treprostinil palmitil inhalation powder (TPIP) program achieved a significant milestone with positive topline data from the Phase 2b PAH study in June 2025. The study met its primary endpoint, demonstrating statistically significant placebo-adjusted reductions in pulmonary vascular resistance (PVR). All secondary efficacy endpoints were also achieved, including improvements in six-minute walk distance (6MWD) and reductions in N-terminal pro b-type natriuretic peptide (NT-proBNP) concentration.
Lewis noted that the Phase 2b PAH study results "surpassed our expectations," positioning TPIP as a potentially differentiated once-daily prostanoid therapy. The company plans to initiate Phase 3 studies for pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the second half of 2025 and for PAH in early 2026.
Gene Therapy Pipeline Progresses
Insmed dosed the first patient in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for Duchenne muscular dystrophy (DMD), in July 2025. The company's gene therapy portfolio includes candidates targeting amyotrophic lateral sclerosis (ALS) and Stargardt disease, with IND filings anticipated in the second half of 2025 for ALS and the first half of 2026 for Stargardt disease.
Financial Position and Outlook
Insmed reported a net loss of $321.7 million, or $1.70 per share, for the second quarter of 2025, compared to a net loss of $300.6 million, or $1.94 per share, for the same period in 2024. The company maintains a strong balance sheet with approximately $1.9 billion in cash, cash equivalents, and marketable securities as of June 30, 2025.
Research and development expenses increased to $177.2 million from $146.7 million in the prior year quarter, primarily reflecting manufacturing expenses and increased headcount. Selling, general and administrative expenses rose to $154.8 million from $106.6 million, driven by commercial readiness activities for brensocatib.
The company reiterates its 2025 global ARIKAYCE revenue guidance range of $405 million to $425 million, representing 11% to 17% year-over-year growth. Insmed completed a public offering in June 2025, raising approximately $823.1 million in net proceeds to support its expanding pipeline and commercial activities.
