• Insmed reported that the FDA previously accepted its supplemental New Drug Application for ARIKAYCE for MAC lung disease under Priority Review, supported by positive Phase 3b ENCORE data that met primary and multiplicity controlled secondary endpoints.
• The ENCORE results and Priority Review position ARIKAYCE as a potential earlier line option in MAC treatment and reinforce Insmed’s focus on expanding its established rare disease franchise while preparing for future product launches.
• The focus now turns to how Insmed’s investment narrative could evolve given the Priority Review of ARIKAYCE’s sNDA based on the ENCORE outcomes.

See how the ARIKAYCE Priority Review fits into the broader rare disease opportunity set by comparing Insmed to