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Is DefenCath Sufficient to Support CorMedix's Long-Term Growth Path?
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Key Takeaways
CorMedix launched DefenCath in 2024 after FDA approval as the first antimicrobial catheter lock solution.
DefenCath generated $78.8M in net revenues in H1 2025, showing early commercial traction.
Patent protection through 2033 and U.S. reimbursement access support DefenCath's growth runway.
CorMedix’s (CRMD - Free Report) lead drug, DefenCath (Taurolidine + Heparin), is currently its only marketed product that generates revenues for the company.
The FDA approved CorMedix’s DefenCath in late 2023 as the first and only antimicrobial catheter lock solution in the United States. The drug is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure who receive chronic hemodialysis through a central venous catheter. CRBSIs can delay treatment and raise healthcare costs through extended hospital stays, intensive therapies and higher mortality. With DefenCath, CorMedix aims to meet this critical unmet medical need.
The 2023 FDA approval was based on the success of a phase III study of DefenCath, where treatment with the drug reduced the risk of CRBSI by up to 71%. Subsequently, CorMedix launched the product commercially in April 2024 in the inpatient setting and in July 2024 in the outpatient hemodialysis setting.
In the first half of 2025, DefenCath delivered $78.8 million in net revenues, reflecting a solid start to its commercial journey. However, adoption in the U.S. market remains in its early stages. Importantly, DefenCath holds a unique market position as the only FDA-approved therapy for a niche condition, supported by patent protection through 2033. This exclusivity provides a long runway for revenue generation.
Looking ahead, sales are expected to build steadily as CorMedix expands its commercial footprint and strengthens its marketing infrastructure. Moreover, eligibility for reimbursement in the U.S. healthcare system enhances patient access and should serve as a strong catalyst for growth in the years ahead.
Other Companies That Market Heparin
DefenCath combines taurolidine, an antimicrobial agent, with the anticoagulant heparin in a fixed-dose formulation designed for a niche population of kidney failure patients. While CorMedix currently enjoys a first-mover advantage in the United States with no direct competitors in CRBSI prevention, the competitive landscape carries risks. Larger players, such as Pfizer (PFE - Free Report) , Amphastar Pharmaceuticals (AMPH - Free Report) , B. Braun, Baxter and Fresenius Kabi USA LLC, already market heparin across a range of indications in the United States. With their deeper pipelines, manufacturing scale and financial resources, these companies could quickly emerge as formidable rivals if they choose to pursue CRBSI-specific applications, potentially eroding CorMedix’s market exclusivity and long-term growth prospects.
Pfizer already markets Heparin Sodium Injection, an anticoagulant with broad clinical applications ranging from the treatment of venous thrombosis and pulmonary embolism to use in surgery, dialysis, and transfusion settings. Backed by its global scale, extensive clinical infrastructure and financial resources, Pfizer could quickly pivot to CRBSI-specific indications, posing a significant challenge to CorMedix’s foothold.
Amphastar currently markets Enoxaparin, a complex low molecular weight heparin with multiple indications. AMPH controls its entire supply chain by producing the active pharmaceutical ingredient in-house, giving it stronger cost efficiencies and quality oversight. This vertically integrated model, combined with Amphastar’s manufacturing expertise, underscores the competitive risk for CorMedix if the company decides to extend its anticoagulant capabilities into the CRBSI market targeted by DefenCath.
CRMD’s Stock Price, Valuation and Estimates
Shares of CorMedix have surged 83.1% so far this year compared with the industry’s 2.7% growth. The stock has also outperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
CRMD Stock Price Movement
Image Source: Zacks Investment Research
From a valuation standpoint, CorMedix stock is expensive. Going by the price/book ratio, the company’s shares currently trade at 4.56 trailing 12-month book value per share, higher than 3.09 for the industry. The stock is also trading above its five-year mean of 3.55.
CRMD Stock Valuation
Image Source: Zacks Investment Research
Estimates for CorMedix’s 2025 earnings have improved from $1.10 to $1.49 per share in the past 60 days, and estimates for 2026 earnings have improved from $1.46 to $2.16 over the same timeframe.
Image: Bigstock
Is DefenCath Sufficient to Support CorMedix's Long-Term Growth Path?
Key Takeaways
CorMedix’s (CRMD - Free Report) lead drug, DefenCath (Taurolidine + Heparin), is currently its only marketed product that generates revenues for the company.
The FDA approved CorMedix’s DefenCath in late 2023 as the first and only antimicrobial catheter lock solution in the United States. The drug is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure who receive chronic hemodialysis through a central venous catheter. CRBSIs can delay treatment and raise healthcare costs through extended hospital stays, intensive therapies and higher mortality. With DefenCath, CorMedix aims to meet this critical unmet medical need.
The 2023 FDA approval was based on the success of a phase III study of DefenCath, where treatment with the drug reduced the risk of CRBSI by up to 71%. Subsequently, CorMedix launched the product commercially in April 2024 in the inpatient setting and in July 2024 in the outpatient hemodialysis setting.
In the first half of 2025, DefenCath delivered $78.8 million in net revenues, reflecting a solid start to its commercial journey. However, adoption in the U.S. market remains in its early stages. Importantly, DefenCath holds a unique market position as the only FDA-approved therapy for a niche condition, supported by patent protection through 2033. This exclusivity provides a long runway for revenue generation.
Looking ahead, sales are expected to build steadily as CorMedix expands its commercial footprint and strengthens its marketing infrastructure. Moreover, eligibility for reimbursement in the U.S. healthcare system enhances patient access and should serve as a strong catalyst for growth in the years ahead.
Other Companies That Market Heparin
DefenCath combines taurolidine, an antimicrobial agent, with the anticoagulant heparin in a fixed-dose formulation designed for a niche population of kidney failure patients. While CorMedix currently enjoys a first-mover advantage in the United States with no direct competitors in CRBSI prevention, the competitive landscape carries risks. Larger players, such as Pfizer (PFE - Free Report) , Amphastar Pharmaceuticals (AMPH - Free Report) , B. Braun, Baxter and Fresenius Kabi USA LLC, already market heparin across a range of indications in the United States. With their deeper pipelines, manufacturing scale and financial resources, these companies could quickly emerge as formidable rivals if they choose to pursue CRBSI-specific applications, potentially eroding CorMedix’s market exclusivity and long-term growth prospects.
Pfizer already markets Heparin Sodium Injection, an anticoagulant with broad clinical applications ranging from the treatment of venous thrombosis and pulmonary embolism to use in surgery, dialysis, and transfusion settings. Backed by its global scale, extensive clinical infrastructure and financial resources, Pfizer could quickly pivot to CRBSI-specific indications, posing a significant challenge to CorMedix’s foothold.
Amphastar currently markets Enoxaparin, a complex low molecular weight heparin with multiple indications. AMPH controls its entire supply chain by producing the active pharmaceutical ingredient in-house, giving it stronger cost efficiencies and quality oversight. This vertically integrated model, combined with Amphastar’s manufacturing expertise, underscores the competitive risk for CorMedix if the company decides to extend its anticoagulant capabilities into the CRBSI market targeted by DefenCath.
CRMD’s Stock Price, Valuation and Estimates
Shares of CorMedix have surged 83.1% so far this year compared with the industry’s 2.7% growth. The stock has also outperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
CRMD Stock Price Movement
From a valuation standpoint, CorMedix stock is expensive. Going by the price/book ratio, the company’s shares currently trade at 4.56 trailing 12-month book value per share, higher than 3.09 for the industry. The stock is also trading above its five-year mean of 3.55.
CRMD Stock Valuation
Estimates for CorMedix’s 2025 earnings have improved from $1.10 to $1.49 per share in the past 60 days, and estimates for 2026 earnings have improved from $1.46 to $2.16 over the same timeframe.
CRMD Estimate Movement
CorMedix currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.