08:31 AM EDT, 03/23/2026 (MT Newswires) -- Insmed ( INSM ) said Monday that a phase 3b study of Arikayce as part of a multidrug regimen to treat patients with Mycobacterium avium complex, or MAC, lung infection who have not started antibiotics has met its primary and secondary endpoints.

The company said the study fulfilled a US Food and Drug Administration post-marketing requirement for Arikayce, which has an existing refractory indication in the US, and strengthens its clinical foundation.

Insmed ( INSM ) said it plans to file a supplemental new drug application with the FDA in H2 seeking a label expansion for Arikayce to include patients with a new MAC infection and support traditional approval for the refractory indication.

The company also said it plans to submit the data in H2 to Japan's Pharmaceuticals and Medical Devices Agency to support potential label expansion in the country.

Shares of Insmed ( INSM ) were up 10.5% pre-bell Monday.