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Insmed Inc.

FDA Approves Insmed's BRINSUPRI for Non-Cystic Fibrosis Bronchiectasis

| 8-K |Healthcare

Summary

On August 12, 2025, Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved BRINSUPRI (brensocatib), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children aged 12 and older. This approval marks the first treatment available for NCFB, a chronic lung disease affecting approximately 500,000 patients in the U.S. The decision is based on the results of Phase 3 ASPEN and Phase 2 WILLOW studies, which demonstrated that BRINSUPRI significantly reduced the annual rate of exacerbations and improved lung function. Insmed plans to host a conference call to discuss the approval and will launch the treatment through a specialty pharmacy network.

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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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