CorMedix's DefenCath Aims to Tackle Catheter-Related Blood Stream Infections: Analyst

RBC Capital Markets initiated coverage on CorMedix Inc CRMD with an Outperform rating and a price target of $6.

CorMedix's antimicrobial asset, DefenCath, can transition the company's execution story with the potential to capture an attractive hemodialysis market.

Despite previous CRLs, DefenCath's data remains robust. The Phase 3 LOCK-IT-100 study in patients undergoing hemodialysis therapy for ESRD demonstrated strong safety and efficacy in preventing CRBSIs. The Phase III LOCK-IT-100 trial results, which analyzed data from 795 out of 806 patients, are promising. 

The analyst Gregory Renza is impressed with CRMD's robust launch and reimbursement plans for inpatient and outpatient contexts, aiming for a peak potential of $600 million in the U.S. by the 2030s. 

Furthermore, potential expansion into pediatric hemodialysis, oncology, and total parenteral nutrition may provide enduring avenues for growth.

The analyst writes that though the November 15 FDA decision date comes with binary risk and historical PDUFA-stage share volatility, DefenCath's resubmission has improved its positioning and is more likely than not to be approved.

Should DefenCath be approved, the analyst sees an upside in sequence through CRMD's launch and DefenCath's market formation.

Price Action: CRMD shares are up 1.84% at $4.42 on the last check Thursday.