INSM PDUFA decision: Thursday, January 28, 2027

…x (MAC) lung disease as part of a combination antibacterial drug regimen. The FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA). • Insmed plans to submit data from the Phase 3 ENCORE study to Japan’

Dates are sourced from official registries and filings and can change — estimated dates (marked ~) slip routinely. This page updates automatically when the source registry moves the date. Research information only, not investment advice.