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Will CorMedix's DefenCath Edge Last If Bigger Heparin Rivals Close In?
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Key Takeaways
CorMedix's DefenCath is the first FDA-approved antimicrobial catheter lock solution in the U.S. market.
Pfizer and Amphastar's heparin products pose potential future competition to CRMD's CRBSI market position.
The $300M Melinta deal adds seven drugs, expanding CorMedix's hospital and infectious disease portfolio.
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. The product was commercially launched in April 2024 in the inpatient setting and in July 2024 in the outpatient hemodialysis setting.
DefenCath combines taurolidine, an antimicrobial agent, with heparin, an anticoagulant, in a fixed-dose formulation designed for a niche population of patients with kidney failure. 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.
Is CorMedix Diversifying to Offset Heparin Market Risks?
CorMedix recently took a strategic step to diversify its revenues and reduce reliance on a single product through its $300 million acquisition of Melinta Therapeutics.
The deal added seven marketed therapies to its portfolio, strengthening the company’s position in hospital acute care and infectious disease markets and supporting near-term growth opportunities, particularly with Rezzayo, which is currently approved for treating candidemia and invasive candidiasis in adults.
Rezzayo is also being evaluated in a phase III study for prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant, with study completion expected in the first half of 2026. If successful, the phase III data will support a regulatory filing for Rezzayo in this additional indication.
CorMedix’s acquisition of Melinta is partly a strategic hedge against potential competition in the CRBSI market from established heparin players like Pfizer and Amphastar Pharmaceuticals.
CRMD’s Stock Price, Valuation and Estimates
Shares of CorMedix have surged 42.7% so far this year compared with the industry’s 8.3% 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 4.09 trailing 12-month book value per share, higher than 3.37 for the industry. The stock, however, is trading below its five-year mean of 3.54.
CRMD Stock Valuation
Image Source: Zacks Investment Research
Estimates for CorMedix’s 2025 earnings have improved from 97 cents to $1.83 per share in the past 60 days, and estimates for 2026 earnings have improved from $1.65 to $2.48 over the same timeframe.
Image: Bigstock
Will CorMedix's DefenCath Edge Last If Bigger Heparin Rivals Close In?
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. The product was commercially launched in April 2024 in the inpatient setting and in July 2024 in the outpatient hemodialysis setting.
DefenCath combines taurolidine, an antimicrobial agent, with heparin, an anticoagulant, in a fixed-dose formulation designed for a niche population of patients with kidney failure. 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.
Is CorMedix Diversifying to Offset Heparin Market Risks?
CorMedix recently took a strategic step to diversify its revenues and reduce reliance on a single product through its $300 million acquisition of Melinta Therapeutics.
The deal added seven marketed therapies to its portfolio, strengthening the company’s position in hospital acute care and infectious disease markets and supporting near-term growth opportunities, particularly with Rezzayo, which is currently approved for treating candidemia and invasive candidiasis in adults.
Rezzayo is also being evaluated in a phase III study for prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant, with study completion expected in the first half of 2026. If successful, the phase III data will support a regulatory filing for Rezzayo in this additional indication.
CorMedix’s acquisition of Melinta is partly a strategic hedge against potential competition in the CRBSI market from established heparin players like Pfizer and Amphastar Pharmaceuticals.
CRMD’s Stock Price, Valuation and Estimates
Shares of CorMedix have surged 42.7% so far this year compared with the industry’s 8.3% 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 4.09 trailing 12-month book value per share, higher than 3.37 for the industry. The stock, however, is trading below its five-year mean of 3.54.
CRMD Stock Valuation
Estimates for CorMedix’s 2025 earnings have improved from 97 cents to $1.83 per share in the past 60 days, and estimates for 2026 earnings have improved from $1.65 to $2.48 over the same timeframe.
CRMD Estimate Movement
CorMedix currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.