ARTICLE | Company News

Aradigm's Linhaliq gets PDUFA date

September 25, 2017 9:38 PM UTC

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...

BCIQ Company Profiles

Aradigm Corp.

Grifols S.A.

BCIQ Target Profiles

DNA gyrase