Ladenburg Thalmann downgraded Aradigm (NASDAQ:ARDM) to “neutral” from “buy” and removed its previous $10 price target. The stock closed at $3.42 on Jan. 16.
On Jan 11, the Antimicrobial Drugs Advisory Committee of the FDA voted against approval of the company’s Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients, with chronic lung Pseudomonas aeruginosa infections.
Analyst Matthew Kaplan writes that the committee could not reconcile the mixed results for the two ORBIT Phase 3 trials for the program to recommend approval of the product.
However, he said that despite the negative vote by the committee, “we continue to believe, based on the positive results for the ORBIT 4 trial, the positive data in the combined ORBIT 3 plus ORBIT 4 analysis, the supportive evidence of ORBIT 3, which showed all endpoints trended in favor of Linhaliq vs. placebo, the supportive results from the Phase 2 study, the clean safety profile in both studies and the significant unmet need in the treatment of NCFBE, the FDA could decide to approve Linhaliq, with the current data potentially combined with a Phase 4 commitment.”
