Aradigm's Linhaliq gets PDUFA date

Aradigm Corp. (NASDAQ:ARDM) gained $0.83 (33%) to $3.36 on Monday after FDA accepted and granted Priority Review to an NDA for Linhaliq liposomal ciprofloxacin (ARD-3150) to treat non-cystic fibrosis bronchiectasis (NCFBE) in patients with chronic Pseudomonas aeruginosa infections. Its PDUFA date is Jan. 26, 2018.

In the U.S., Linhaliq has Fast Track and Qualified Infectious Disease Product (QIDP) designations for the indication, as well as Orphan Drug designation for the management of bronchiectasis...