On May 7, 2026 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

"In the first quarter of 2026, momentum across Insmed’s commercial portfolio and pipeline continued to build," said Will Lewis, Chair and Chief Executive Officer of Insmed. "The trajectory of the BRINSUPRI launch continues to exceed our expectations, and we are especially encouraged by the positive topline results from the ENCORE Phase 3b study, which could enable us to extend our reach to even more patients. We remain focused on improving bronchiectasis diagnosis, expanding the ARIKAYCE label, advancing our Phase 3 programs for TPIP, and progressing our early-stage pipeline, with the ambition of delivering meaningful innovation and improving the lives of patients with serious diseases."

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

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BRINSUPRI

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BRINSUPRI global revenue grew 44% in the first quarter of 2026 compared to the fourth quarter of 2025, driven by strong growth in the U.S. market.

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In February 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization in the United Kingdom (U.K.) for 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 flare-ups or worsening of symptoms in the past 12 months.

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Insmed anticipates a regulatory decision for brensocatib for the treatment of NCFB in Japan in 2026.

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Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

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ARIKAYCE global revenue grew 6% in the first quarter of 2026 compared to the first quarter of 2025, driven by strong growth in international markets.

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In March 2026, Insmed reported positive topline results from the Phase 3b ENCORE study of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease, which met its primary and all multiplicity-controlled secondary culture conversion endpoints.

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Insmed plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (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 (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

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Insmed continues to enroll patients in the PALM-ILD trial, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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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 (PAH).

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In April 2026, Insmed initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH.

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Insmed expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the third quarter of 2026.

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Insmed anticipates initiating a Phase 3 study of TPIP in patients with progressive pulmonary fibrosis (PPF) by the end of 2026 and a Phase 3 study in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.

INS1148

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Insmed plans to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and is exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.

Immunology & Inflammation

INS1033

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Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial investigational new drug (IND) filing expected in the second half of 2026.

Neuro & Other Rare

INS1201

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Insmed continues to enroll patients in the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

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Insmed continues to enroll patients in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

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INS1203

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Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

Corporate Updates

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Insmed plans to present six abstracts from across its Respiratory Therapeutic Area (BRINSUPRI, ARIKAYCE, TPIP) at the American Thoracic Society (ATS) 2026 International Conference, taking place May 15-20, 2026.

(Press release, Insmed, MAY 7, 2026, View Source [SID1234665329])