FDA Grants Priority Review to Insmed's ARIKAYCE sNDA; PDUFA Date Set for January 2027

Insmed Incorporated (INSM) said Monday the U.S. Food and Drug Administration accepted its Supplemental New Drug Application for ARIKAYCE (amikacin liposome inhalation suspension) for review in Mycobacterium avium complex (MAC) lung disease, granting the filing priority review status. The FDA set a Prescription Drug User Fee Act action date of January 2027, according to the company. Priority review shortens the standard review clock and is reserved for therapies that may offer significant improvements over existing treatments. The sNDA seeks to expand ARIKAYCE's label to include MAC lung disease, a rare, chronic bacterial lung infection. Insmed did not disclose additional data from the submission. The company's shares trade on Nasdaq under the ticker INSM.