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How Will DefenCath Aid CRMD's Top Line in the Upcoming Q3 Results?

By Ahan Chakraborty | October 20, 2025, 10:10 AM

CorMedix’s CRMD DefenCath (Taurolidine + Heparin) is its lead marketed product and the primary revenue driver for the company. The FDA approved 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. Investors will be most keen to know the sales numbers of this drug when CRMD reports third-quarter results.

DefenCath occupies a distinctive market position as the only FDA-approved therapy for a niche indication, with patent protection extending through 2033. CorMedix’s revenues in the third quarter of 2025 are expected to be driven by strong market adoption, suggesting significant year-over-year growth, and accounting for most of the company’s total revenues.

CRMD recently took a significant step toward diversifying its revenues and reducing reliance on DefenCath with the $300 million acquisition of Melinta Therapeutics. This move added seven approved therapies to its portfolio, strengthening its presence in hospital acute care and infectious disease markets. The expanded portfolio not only broadened the company’s revenue base but also created near-term growth opportunities, particularly for Rezzayo, which is being evaluated in a phase III study for prophylaxis of invasive fungal infections, with potential label expansion in 2026.

These acquired products from Melinta are anticipated to generate incremental revenues in the third quarter, contributing meaningfully to the company’s top-line growth. The Zacks Consensus Estimate for CorMedix’s total revenues in the third quarter of 2025 is currently pegged at $69.55 million.

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, Amphastar Pharmaceuticals AMPH, 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.

Pfizeralready 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.

AmphastarPharmaceuticalscurrentlymarkets 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 Pharmaceuticals’ manufacturing expertise, underscores the competitive risk for CorMedix if the company decides to extend its anticoagulant capabilities into the CRBSI market targeted by DefenCath.

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Pfizer Inc. (PFE): Free Stock Analysis Report
 
Amphastar Pharmaceuticals, Inc. (AMPH): Free Stock Analysis Report
 
CorMedix Inc (CRMD): Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

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