Arikayce treats adults with nontuberculous mycobacterial (NTM) lung disease who are treatment refractory. The FDA's designation should accelerate Arikayce's development and review. The FDA based its designation on positive data from the company's Phase 2 clinical trial, as well as an unfulfilled need for NTM lung disease treatments.
Insmed now plans to meet with the FDA to talk about the regulatory pathway for Arikayce, which is also being tested as a possible treatment for pseudomonas lung infections patients with cystic fibrosis and non-cystic fibrosis.
The stock was up 39.43% to $17.38 at 11:49 a.m.