FDA Approves Insmed's BRINSUPRI As First-in-Class Treatment For Non-Cystic Fibrosis Bronchiectasis

(RTTNews) - Insmed Inc. (INSM) announced Tuesday that the U.S. Food and Drug Administration approved first-in-class BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

INSM closed Tuesday regular trading at $122.00 up $9.11 or 8.07%. In the after-hours trading the stock further gained $0.03 or 0.02%.

BRINSUPRI is the first and only FDA-approved treatment for non-cystic fibrosis bronchiectasis or NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline.

In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the Company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory.

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