Insmed Inc (NASDAQ:INSM) on Friday outlined a commercial and clinical roadmap for 2026, highlighting strong momentum from its respiratory portfolio and a series of upcoming trial readouts and launches that could shape the company's growth over the next 18 months. • Insmed stock is gaining positive traction. Why are INSM shares climbing?Speaking ahead of Insmed's presentation at the J.P. Morgan Healthcare Conference, Will Lewis, chair and CEO, said 2025 marked a turning point for the company as it translated ...

Core Insights - Insmed's shares fell nearly 20% in after-market trading following the failure of the mid-stage BiRCh study for Brinsupri in chronic rhinosinusitis without nasal polyps [1][7] - The BiRCh study did not meet its primary or secondary efficacy endpoints, leading to the decision to halt Brinsupri's development in this indication [2][7] - Investors were surprised by the negative results, especially after Insmed's recent success with Brinsupri's approval for non-cystic fibrosis bronchiectasis [3][6] Company Performance - Despite the setback, Insmed's shares are still up 187% year-to-date, significantly outperforming the industry average growth of 18% [6] - Brinsupri generated $28 million in sales during Q3 2025, indicating strong initial market uptake [4] - The failure of the BiRCh study has dampened investor enthusiasm for the ongoing phase II CEDAR study for Brinsupri in hidradenitis suppurativa, with results expected in the first half of 2026 [5] Pipeline Expansion - Insmed announced the acquisition of investigational monoclonal antibody INS1148 from Opsidio, aimed at treating respiratory and immunological diseases [9] - The company plans to develop INS1148 in mid-stage studies for interstitial lung disease and moderate-to-severe asthma [9]

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]