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CRMD Up More Than 40% YTD: Time to Buy, Sell or Hold the Stock?

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Key Takeaways

  • CRMD's DefenCath sales hit $167.6M in the first nine months of 2025, driving the stock's YTD surge.
  • Higher outpatient utilization and planned label expansion are expected to support DefenCath growth.
  • The $300M Melinta deal adds seven therapies and diversified opportunities, including Rezzayo.

Shares of CorMedix (CRMD - Free Report) have witnessed a strong surge so far this year, primarily driven by the continued strong uptake of the company’s lead marketed therapy, DefenCath (Taurolidine + Heparin). The stock has rallied 41.4% year to date compared with the industry’s rise of 16.9%. CRMD shares have also outperformed the sector and the S&P 500 in this timeframe, as seen in the chart below.

CRMD Stock Outperforms Industry, Sector & S&P 500

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DefenCath was approved by the FDA in late 2023 as the first and only antimicrobial catheter lock solution available in the United States. It is indicated to lower the risk of catheter-related bloodstream infections (CRBSIs) in adults with kidney failure undergoing chronic hemodialysis via 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.

DefenCath is the first approved product in CorMedix’s marketed portfolio, giving the company a regular income stream. The product has witnessed a strong market adoption so far, and the momentum is expected to continue in 2026.

Let’s analyze CorMedix’s strengths and weaknesses to understand how to play the stock amid the recent share price rally.

CRMD’s DefenCath Witnessing Strong Demand Trends

DefenCath was launched in 2024 in both the hospital inpatient and outpatient hemodialysis settings.

In the first nine months of 2025, DefenCath recorded $167.6 million in net sales, reflecting strong market adoption since its commercial launch. 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 is likely to offer a long runway for revenue generation.

Heading into the new year, sales are expected to grow steadily as CRMD expands its commercial footprint and strengthens its marketing infrastructure, driving continued momentum for DefenCath. Per management, higher-than-expected utilization of DefenCath by outpatient dialysis customers is likely to drive growth in future quarters.

CorMedix is also planning future potential label expansion of DefenCath into total parenteral nutrition to increase its customer base. Upon potential approval, management expects this to drive sustainable near-term growth.

Melinta Acquisition Expands CRMD’s Product Portfolio

CorMedix took a significant step toward diversifying its revenues and reducing dependence on DefenCath with the $300 million acquisition of Melinta Therapeutics. The acquisition, which closed in August 2025, added seven approved therapies to CRMD’s portfolio, strengthening its presence in hospital acute care and infectious disease markets.

These acquired products from Melinta contributed $12.8 million to CRMD’s top line during the third quarter of 2025, representing its partial quarter sales.

The acquisition of Melinta broadened CRMD’s revenue base while creating near-term growth opportunities, particularly with Rezzayo, which is currently approved for the treatment of candidemia and invasive candidiasis in adults. Rezzayo is also in late-stage development for another indication, prophylaxis of invasive fungal infections. Top-line data from this study is expected in the second quarter of 2026.

Management believes that the total addressable market for patients undergoing antifungal prophylaxis is more than $2 billion.

It can be inferred that the Melinta acquisition underscores CorMedix’s long-term strategy to accelerate growth by expanding its hospital-focused offerings while building a more durable, diversified commercial platform.

CRMD’s Competition in the Target Market

DefenCath combines taurolidine, an antimicrobial agent, with heparin in a fixed-dose formulation tailored for a specific subset of kidney failure patients. Although CorMedix currently holds a first-mover advantage in the United States with DefenCath, the broader competitive environment still poses risks. Major players such as Pfizer (PFE - Free Report) , Amphastar Pharmaceuticals (AMPH - Free Report) , B. Braun, Baxter and Fresenius Kabi USA already market heparin for multiple uses.

Given their stronger pipelines, larger manufacturing capabilities and greater financial resources, these companies could quickly become significant competitors if they decide to target CRBSI-related indications — a move that could challenge CorMedix’s market advantage and affect its long-term growth outlook.

Pfizer, which markets Heparin Sodium Injection for a wide range of clinical applications — including dialysis, surgical procedures, and thrombosis management — could use its global scale and clinical expertise to move into the CRBSI prevention segment. Amphastar Pharmaceuticals, meanwhile, manufactures Enoxaparin and controls its entire production chain from API to finished product, giving it the operational efficiency and technical capabilities to pursue similar opportunities. If either Pfizer or Amphastar expands its anticoagulant portfolio into catheter-related infection prevention, CorMedix could encounter significant competitive pressure within its primary therapeutic space.

CRMD Stock Valuation & Estimates

From a valuation standpoint, CorMedix is trading at a discount to the industry. Going by the price/book ratio, the company’s shares currently trade at 2.40 trailing 12-month book value per share, lower than 3.51 for the industry. The stock is also trading below its five-year mean of 3.44.

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Estimates for CorMedix’s 2025 earnings have improved from $1.85 to $2.87 per share in the past 60 days, and estimates for 2026 earnings have improved from $2.49 to $2.88 over the same timeframe.

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How to Play CRMD Stock

We remain optimistic about CorMedix, buoyed by its strong sales performance in the first nine months of 2025 and the upbeat guidance for 2025. Reflecting the growing momentum with DefenCath and early Melinta portfolio contributions, the company raised its full-year 2025 pro forma net revenue guidance to $390-$410 million, up from the prior expectation of at least $375 million.

We expect growth in DefenCath sales to continue to boost the top line. Incremental contributions from its Melinta portfolio should also aid CorMedix’s top line. However, the company’s lack of a deep pipeline and potential competition from established players in the target market remains a concern.

While competitive risks remain from large drugmakers, CorMedix’s unique positioning, growing portfolio and improving earnings estimates present an optimistic outlook. We believe there is more room for growth and recommend prospective investors add this Zacks Rank #1 (Strong Buy) stock to their portfolios at the present attractive valuation for meaningful gains in both the short and long term. You can see the complete list of today’s Zacks #1 Rank stocks here.


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