Insmed Stock Rise on EU Nod for Lung Disease Drug, Brinsupri
InsmedInsmed(US:INSM) ZACKS·2025-11-19 17:01

Core Insights - Insmed (INSM) received European Commission approval for Brinsupri (brensocatib) to treat non-cystic fibrosis bronchiectasis (NCFB), leading to a 2.1% increase in share price [1][6] - Brinsupri is the first and only approved treatment for NCFB in the EU, having undergone accelerated assessment by the European Medicines Agency (EMA) due to its public health significance [2][3] - Year-to-date, Insmed's shares have surged by 192%, significantly outperforming the industry average increase of 15.7% [2] Regulatory Approval - The approval of Brinsupri was based on comprehensive scientific reviews, including data from phase III ASPEN and phase II WILLOW studies [3] - The ASPEN study demonstrated that Brinsupri (25 mg) reduced the annual exacerbation rate by 19.4% compared to placebo, while also meeting key secondary goals [4][6] Commercial Performance - In the third quarter of 2025, Brinsupri generated sales of $28.1 million in the partial quarter following its U.S. approval and launch, indicating a promising commercial start [8] Future Developments - Insmed is also exploring Brinsupri in the phase IIb BiRCh study for chronic rhinosinusitis without nasal polyps (CRSsNP), with data expected in early 2026, and in the phase II CEDAR study for hidradenitis suppurativa, with top-line data anticipated in the first half of 2026 [9]