FDA Taking Priority Review of Aradigm's Inhaler, Shares Keep Jamming Higher

Shares of Aradigm Corp. (NASDAQ:ARDM) have been bolting ahead at a blistering pace for the past few days, surging from a close at $1.40 five trading days ago before more than doubling in value following a key opinion leader call on the topic of infection management in non-cystic fibrosis bronchiectasis (NCFBE) patients last Monday.

During the call, which is directly aligned with Aradigm's pipeline, the Hayward, California-based company also provided a summary on its late-stage study of Linhaliq, an experimental formulation of cirpfloxacin for inhalation by Aradigm.

Linhaliq has been successfully evaluated in two phase 3 clinical trials as a once-per-day inhaler for treating patients with NCFBE suffering from lung infections with Pseudomonas aeruginosa, a common, but hard-to-treat Gram-negative bacteria. Aradigm has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking commercialization of the drug.

Aradigm is developing its pipeline under multiple FDA designations, including an Orphan Drug designation for liposomal ciprofloxacin for inhalation for the management of bronchiectasis, an Orphan Drug designation for Linhaliq for the management of bronchiectasis and Linhaliq as a QIDP (qualified infectious disease product) and Fast Track designation for NCFBE with P. aeruginosa, a disease that affects more than 150,000 Americans.

Monday morning, Aradigm said that the FDA has accepted its NDA for Linhaliq for NCFBE in the specific patient population for Priority Review. As the name implies, the Priority Review process expedites the timing of the FDA review of an application compared to standard lead times. With the new designation, Aradigm is looking for an FDA decision by January 26, 2018.

As a FDA decision approaches, stock values tend to churn upward, as is happening with Aradigm stock. Shares gapped ahead from Friday's close at $2.53 to open today at $3.38. Shares have lost a little steam as the morning wears on, dipping back to $3.14 90 minutes into the session, representing a gain of 24.11%.