Another FDA blow for Aradigm sees shares slump nearly 40%

US specialty drug firm Aradigm (Nasdaq: ARDM) saw its shares plummet at much as 39% to $1.36 in morning trading on Monday, after it said it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Linhaliq (liposomal ciprofloxacin) as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factors validation study and product quality.

The setback should come as no surprise, given that earlier this month an FDA advisory panel voted 12 to 3 against approval of Aradigm’s antibiotic drug Linhaliq, with that news sending Aradigm’s shares down nearly 34% to $2.26 at that time.