Shares of Insmed Inc. INSM more than doubled in pre-market trading Tuesday after the company announced that its new drug, an inhaled antibiotic known as Alis, successfully treated patients with a rare lung disease.
Alis met the main goal in a late-stage study involving 336 adult patients with nontuberculous mycobacterial lung infections. According to Insmed, the addition of the drug showed statistically significant reduction in bacterial density by month six in 29% of patients, compared to just 9% in patients receiving the standard treatment.
After closing at $12.29 per share on Friday afternoon, Insmed soared more than 140% in pre-market trading, opening at $29.50 per share as investors returned from the Labor Day holiday on Tuesday.
Nontuberculous mycobacterial lung infections are caused by a specific type of bacteria found in soil and water, which causes cough, fever and blood in the mucus. As of right now, there is no approved treatment for these type of infections.
Based on the latest data, Insmed now plans to apply for accelerated approval for Alis. The FSA had previously fast-tracked the drug and granted it breakthrough therapy designation.
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