INSM stock dropped on news that a Phase II study of Arikayce, considered a leading product candidate for the treatment of lung infections, failed to demonstrate significant improvement in mycobacterial density in patients suffering from nontuberculous mycobacterial lung infections, compared to those receiving a placebo, the Wall Street Journal noted.
However, INSM noted that the drug had shown success in producing negative cultures in patients, a secondary goal in the Phase II study. INSM indicated that it would apply for breakthrough therapy designation for the drug with the U.S. Food and Drug Administration.
Arikayce has received orphan drug status from U.S. regulators, who have also fast-tracked it.
INSM stock closed at $18.30 per share on Tuesday. Insmed stock has gained more than 140% over the past 12 months.