(Reuters) - The US Food and Drug Administration (FDA) on Wednesday approved CorMedix's antimicrobial drug for reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney disease, allowing the company to launch its first commercial product.
The company plans to ready the drug for commercialization by end of the first quarter of 2024, CorMedix CEO Joe Todisco told Reuters.
Shares of the New Jersey-based company rose 32% by mid-day, helped also by a smaller-than-expected loss for the third quarter reported earlier in the day.
DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the FDA on manufacturing concerns.
In 2021, the FDA cited doubts about the third-party manufacturing facility for DefenCath and a year later, raised concerns related to the supplier of heparin.
Ahead of the drug approval, CorMedix said it had changed its heparin supplier and the FDA had inspected its current manufacturing facility and was comfortable with it.
Brokerage RBC said that CorMedix's steps, such as recent hirings and having a ready inventory of the drug, could help with a successful launch for DefenCath.
RBC added that the company does not see any meaningful revenue contributions from the drug until the second half of 2024.
