Roth Capital Partners launched coverage of CorMedix (NASDAQ:CRMD) with a “buy” rating and price target of $6. The stock closed at $1.35 on Dec. 4.
CorMedix is developing Neutrolin for the prevention of catheter-related blood stream infections (CRBSIs) in patients with central venous catheters (CVCs) and as a catheter lock solution for hemodialysis patients with CVCs. Neutrolin contains taurolidine, a broad spectrum anti-infective with activity against bacteria, fungi, and biofilms.
Analyst Jerry Isaacson writes that there is a large market opportunity for Neutrolin in multiple patient populations. CorMedix has fast-track designation from the FDA and a qualified infectious disease product designation, leading to 10.5 years of market exclusivity.
In July, CorMedix stopped its Phase 3 LOCK-IT-100 trial after it had met the primary efficacy endpoint at the interim analysis and the Data Safety Monitoring Board indicated there were no safety concerns with Neutrolin.
CorMedix plans to meet with the FDA, “after which time we expect detailed trial results,” Mr. Isaacson said. The FDA meeting will define a path to market and potential label for Neutrolin.
Mr. Isaacson said his $6 price target is supported by currently available data, but “we believe there is potential upside in terms of pricing, label expansion into other types of CVC patients, and more aggressive sales in the EU, where the product is already approved for sale.”
