Insmed Inc. (NASDAQ:INSM) said FDA accepted and granted Priority Review to an NDA for ALIS (amikacin liposome inhalation suspension) to treat non-tuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). The PDUFA date is Sept. 28.
The company said it expects an advisory committee meeting to discuss the NDA.
Last September, Insmed reported ALIS met the primary endpoint in a Phase III trial in the indication (see BioCentury Extra, Sept. 5, 2017).
Insmed gained $0.69 to $27.89 on Wednesday.