Insmed Surges 8.07% on FDA Approval as $870M Trading Volume Hits Top 500 Daily Rank

Insmed (INSM) surged 8.07% on August 12, 2025, with a trading volume of $0.87 billion, a 132.3% increase from the prior day. The rally followed the U.S. Food and Drug Administration’s (FDA) approval of BRINSUPRI™ (brensocatib), the first and only treatment for non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease affecting approximately 500,000 U.S. patients. The drug, a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, targets neutrophilic inflammation, addressing a root cause of exacerbations in NCFB. Clinical trials, including the Phase 3 ASPEN and Phase 2 WILLOW studies, demonstrated significant reductions in annual exacerbation rates and improved lung function preservation compared to placebo.

The FDA approval marks a milestone for Insmed and the NCFB patient community, offering a novel therapeutic option for a disease historically managed only through symptomatic treatments. BRINSUPRI’s mechanism inhibits enzymes driving chronic airway inflammation, with 48.5% of patients remaining exacerbation-free after 52 weeks in the ASPEN trial. The therapy is now available in the U.S. through specialty pharmacies, and regulatory submissions in Europe and Japan are underway, with commercial launches anticipated in 2026 pending approvals. The drug’s safety profile includes common adverse reactions such as upper respiratory infections and hyperkeratosis, with no major safety concerns reported in pivotal trials.

Insmed’s management highlighted the approval as a transformative step for NCFB care, with the potential to become a new standard. The company emphasized its commitment to expanding access through patient support programs and partnerships with healthcare providers. Forward-looking statements caution risks, including regulatory delays and market acceptance uncertainties, but the approval underscores Insmed’s focus on first-in-class therapies for underserved respiratory diseases. The stock’s sharp volume increase and price surge reflect investor optimism around the drug’s commercial potential and its role in addressing a significant unmet medical need.

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