Insmed Phase III Date Support Accelerated Approval For ALIS In Rare Lung Disease

Insmed Inc. will seek accelerated approval for amikacin liposome inhalation suspension (ALIS) after the drug candidate formerly known as Arikayce eliminated the bacterial evidence of a rare lung disease in a Phase III clinical trial, pursuing a path originally shot down by the US FDA in 2014.

Bridgewater, NJ-based Insmed's stock price more than doubled on Sept. 5 – rising 119.6% to close at $26.99 – after the company revealed that ALIS plus guideline-based therapy (GBT) met its primary endpoint of culture conversion by month six in adults with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex (MAC)