07:15 AM EDT, 05/28/2024 (MT Newswires) -- Insmed ( INSM ) said Tuesday that its experimental drug, brensocatib, for the treatment of bronchiectasis lung disease, has met the primary endpoint in a late-stage study.
The company said brensocatib was statistically significant in reducing the annualized rate of pulmonary exacerbations when compared to placebo.
It said the drug has also met several of its pre-specified secondary endpoints with statistical significance. Based on these results, Insmed ( INSM ) plans to submit a New Drug Application with the US Food and Drug Administration for brensocatib in Q4.
If approved, the drug is expected to launch in the US by mid-2025, with Europe and Japan following in the first half of 2026, Insmed ( INSM ) said.
Insmed ( INSM ) shares rose 127% in recent premarket trading.
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