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Form 8-K · Current Report · Filed 2025-11-18

Insmed Announces EC Approval of BRINSUPRI for Non-Cystic Fibrosis Bronchiectasis

Insmed Incorporated announced on November 18, 2025, that the European Commission has approved 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 exacerbations in the prior 12 months.

Filer
Insmed Inc. INSM · NASDAQ
Filed
Accession
0001140361-25-042598
CIK
0001104506
Signal
High impactHealthcare

Details

This marks the first and only approved treatment for NCFB in the European Union. The approval is based on positive results from Phase 3 ASPEN and Phase 2 WILLOW studies, which demonstrated a significant reduction in the annual rate of exacerbations and improvement in lung function.

Items reported

Item 7.01

Regulation FD Disclosure

Regulation FD Disclosure
Item 8.01

Other Events

Regulatory Approval
Item 9.01

Financial Statements and Exhibits

Exhibits Furnished

Market reaction

Close before filing

$197.40

Next session

+3.1%

Since filing

-50.1%

Latest close

$98.60

What happened, not what will happen — closing prices around the filing date.

Precedent

Previous filings from INSM reporting the same item, with the next session's move:

About Insmed Inc.

Insmed Inc. is a biopharmaceutical company dedicated to enhancing the lives of patients with rare diseases. The company's primary focus is on the development and commercialization of treatments for serious and rare disorders, particularly in the fields of pulmonology and infectious diseases. One of Insmed's noteworthy products is Arikayce, an inhaled antibiotic that addresses specific pulmonary infections often affecting patients with underlying lung conditions. Insmed Inc. also undertakes robust research and development efforts to boost its pipeline of potential therapies, aiming to address unmet medical needs. Operating within the broader healthcare sector, Insmed is a key player in the biopharmaceutical landscape, driven by innovation and scientific research. The company’s continued advancements and strategic collaborations underscore its commitment to elevating patient care and expanding treatment options for rare disease patients. This aligns Insmed as a significant entity in the realm of specialized healthcare solutions, reflecting its impact on the biopharmaceutical market.

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