FDA grants priority review to Insmed SNDA for Arikayce
FDA granted priority review to Insmed's SNDA for Arikayce to treat mac lung disease. The PDUFA target action date is January 28, 2027.
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FDA grants Priority Review for Insmed’s ARIKAYCE sNDA; PDUFA Jan. 28, 2027
Insmed said the FDA granted Priority Review for its ARIKAYCE sNDA for MAC lung disease, with a PDUFA date of Jan. 28, 2027. Roth Capital cut its price target on INSM from $212 to $198.
FDA grants priority review to Insmed's ARIKAYCE for MAC lung disease
FDA accepted Insmed's supplemental New Drug Application (sNDA) for ARIKAYCE in MAC lung disease as part of combination therapy, granting Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is set for Jan. 28, 2027. The filing seeks full approval, supported by Phase 3b ENCORE results.
FDA grants priority review to Insmed ARIKAYCE sNDA
FDA granted priority review to Insmed's supplemental new drug application (sNDA) for ARIKAYCE® (amikacin liposome inhalation suspension) to treat MAC lung disease. The Prescription Drug User Fee Act (PDUFA) target action date is January 28, 2027.