INSM ▲ +4.5% - Insmed Incorporated $INSM INSM - FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027 Insmed shares rose 4.5% following the FDA's grant of priority review status for a supplemental new drug application seeking to expand ARIKAYCE's use to nontuberculous mycobacteria (MAC) lung disease, with a decision expected by January 28, 2027. Priority review designation accelerates the agency's evaluation timeline and suggests the regulator views the application as addressing an unmet medical need, potentially opening a new patient population for the company's inhaled antibiotic therapy. 21-SEP-2026 07:00 AM ET