BERKELEY HEIGHTS, N.J., Feb. 02, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced its Board of Directors has approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. The repurchase program is authorized through December 31, 2027. “With a strong balance sheet, s ...

Core Insights - CorMedix Inc. (CRMD) is recognized as a high growth small-cap stock, particularly noted for its potential in the biopharmaceutical sector [1] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products aimed at preventing and treating serious diseases. Its primary product, DefenCath, is an FDA-approved catheter lock solution designed to reduce bloodstream infections in hemodialysis patients [4] Analyst Ratings and Price Targets - H.C. Wainwright has lowered its price target for CRMD from $18 to $13 while maintaining a Buy rating, indicating a shift in focus towards clinical results over commercial performance for the company's future [2] - RBC Capital has also reduced its price target for CRMD from $22 to $13, while keeping an Outperform rating, following updates to their models based on discussions with management [3]

Key Takeaways CorMedix's shares fell 31% in a month after management issued conservative 2026 revenue guidance.CRMD guided 2026 revenues of $300-$320M, with DefenCath sales expected to be $150-$170 million.CRMD added diversification via the Melinta deal, with seven drugs and likely near-term growth from Rezzayo.Shares of CorMedix (CRMD) have declined sharply over the past month, reflecting investor concerns following its bearish 2026 financial outlook. The guidance points to a more conservative growth traje ...

Core Insights - CorMedix's lead product, DefenCath, is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., launched in 2024, primarily targeting catheter-related bloodstream infections in kidney failure patients undergoing hemodialysis [1][2] - DefenCath generated $167.6 million in net sales in the first nine months of 2025, with a unique market position supported by patent protection until 2033 [2][3] - CorMedix's acquisition of Melinta Therapeutics for $300 million aims to diversify revenue streams and enhance its presence in hospital acute care and infectious disease markets [3] Financial Performance - Preliminary unaudited pro forma net revenues for CorMedix in 2025 are approximately $400 million, aligning with the company's guidance of $390 million to $410 million [3] - For 2026, CorMedix has provided revenue guidance of $300-$320 million, with DefenCath expected to contribute $150-$170 million [4][10] - Adjusted EBITDA for 2026 is projected to be between $100 million and $125 million [5] Market Dynamics - DefenCath's sales are expected to be stronger in the first half of 2026, but ongoing pricing pressure and flat usage among existing customers may hinder growth [5][10] - Competition from major players like Pfizer and Amphastar Pharmaceuticals poses a risk, as they could leverage their resources to enter the catheter-related infection prevention market [6][9][11] Stock Performance and Valuation - CorMedix's stock has decreased by 36.1% over the past six months, underperforming the industry growth of 18.7% [12] - The company's shares are trading at a price/book ratio of 1.57, below the industry average of 3.58, indicating a discount in valuation [13] - Earnings estimates for 2025 have decreased from $2.87 to $2.82 per share, while 2026 estimates have dropped from $2.88 to $1.78 [14]

Core Insights - CorMedix (CRMD) and Mirum Pharmaceuticals (MIRM) attract investors in the rare-disease biotech sector due to smaller patient populations that can yield significant revenue through premium pricing and regulatory incentives [1] - Both companies benefit from clearer clinical endpoints and faster regulatory pathways, allowing quicker market entry compared to traditional drugs [1] CorMedix (CRMD) Overview - CorMedix's lead product, DefenCath, received FDA approval in late 2023 as the first antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in kidney failure patients [2] - DefenCath generated $167.6 million in net sales in the first nine months of 2025, indicating strong market adoption [7] - The company plans to expand DefenCath's label into total parenteral nutrition and has diversified its revenue through a $300 million acquisition of Melinta Therapeutics, adding seven approved therapies to its portfolio [7] - Despite initial success, CorMedix's future outlook is cautious, with 2026 revenue guidance of $300-$320 million and projected 2027 revenues of $100-$140 million, reflecting pricing pressures and limited growth [8][11] Mirum Pharmaceuticals (MIRM) Overview - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and has seen a 70% year-over-year increase in net sales, reaching $161.4 million in the first nine months of 2025 [3][12] - The company has expanded its portfolio with a new tablet formulation of Livmarli and additional bile acid products from the acquisition of Travere Therapeutics, generating $118.8 million in the first nine months of 2025 [16] - MIRM's revenue guidance for 2026 is approximately $630-$650 million, supported by a broader product base and ongoing clinical studies for new therapies [16][28] Comparative Analysis - Both companies exhibit a similar risk-reward profile, but MIRM presents a clearer growth narrative with multiple revenue drivers, while CRMD's outlook is clouded by conservative guidance and reliance on a single product [4][9] - MIRM's shares have increased by 75.3% over the past six months, contrasting with CRMD's 38% decline, indicating market preference for MIRM's growth potential [23] - Valuation metrics show MIRM trading at a price/book ratio of 16.02, significantly higher than CRMD's 1.43, reflecting investor confidence in MIRM's growth prospects [24] Investment Recommendation - Mirum Pharmaceuticals is viewed as the better investment opportunity due to its strong sales growth, diversified revenue streams, and multiple growth levers, while CorMedix faces more uncertainty and competitive pressures [25][29]

Core Insights - CorMedix's lead product, DefenCath, is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections (CRBSIs) in adult patients undergoing chronic hemodialysis [1][10] - DefenCath was launched in 2024 and is protected by patents until 2033, with plans for label expansion into total parenteral nutrition [2] - The company reported preliminary revenues of approximately $127 million for Q4 2025 and $310 million for the full year, with adjusted EBITDA expected between $77-$81 million for Q4 2025 [4][6] Product and Market Position - DefenCath's unique market position as the only FDA-approved therapy for a niche condition supports its revenue growth, with expectations of it being a key driver in Q4 2025 [2][10] - CorMedix's acquisition of Melinta Therapeutics for $300 million has diversified its revenue streams and strengthened its presence in hospital acute care and infectious disease markets, contributing $12.8 million in revenues in Q3 2025 [3] Financial Performance - Pro forma net revenues for full-year 2025 were around $400 million, with cash and short-term investments reported at approximately $148 million as of December 31, 2025, indicating improved financial flexibility [5] - For 2026, total revenue expectations are between $300-$320 million, with DefenCath projected to contribute $150-$170 million [6] Competitive Landscape - CorMedix faces strong competition from established players in the heparin market, such as Pfizer and Amphastar Pharmaceuticals, which could pose risks to its market advantage [7][9] - Major competitors have the potential to enter the CRBSI prevention market, which could challenge CorMedix's growth outlook [8][12] Stock Performance and Valuation - CorMedix's stock has declined by 36.3% over the past six months, underperforming the industry growth of 21.1% [13] - The company's shares are trading at a price/book ratio of 1.49, lower than the industry average of 3.56, indicating a discount in valuation [14] - Earnings estimates for 2025 have increased from $2.57 to $2.85 per share, while estimates for 2026 have decreased from $2.72 to $2.37 [17]

Core Viewpoint - CorMedix Inc. is under investigation for potential violations of federal securities laws following a significant revenue guidance reduction due to changes in reimbursement policy for its product DefenCath [1][2]. Financial Performance - CorMedix announced preliminary fourth quarter and full year 2025 results, revealing a revenue guidance cut from $400 million to a range of $300 million to $320 million [2]. - The anticipated reimbursement policy change for DefenCath is expected to significantly reduce institutional reimbursement levels and net pricing in the second half of 2026 [2]. Market Reaction - Following the announcement of the revenue guidance reduction, CorMedix's stock price fell over 21%, opening at $8.73 per share [2].

Core Insights - CorMedix Therapeutics has announced changes in its executive leadership, with CEO Joseph Todisco extending his contract and taking on the role of Chairman of the Board, succeeding Myron Kaplan, who will become the Lead Independent Director [1][2][3] Leadership Changes - Joseph Todisco's extended contract reflects his long-term commitment to CorMedix, and his transition to Chairman is seen as a strategic move to strengthen the company for future success [1][2] - Mike Seckler has been appointed as EVP & Chief Commercial Officer, bringing extensive experience in hematology and oncology, previously serving as CEO of Evome Medical Technologies Inc. [2][3] Company Overview - CorMedix is focused on developing and commercializing therapeutic products for life-threatening conditions, including its product DefenCath, which is aimed at preventing catheter-related bloodstream infections in hemodialysis patients [4] - Following the acquisition of Melinta Therapeutics LLC in August 2025, CorMedix is also commercializing a range of anti-infective products, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV™, BAXDELA, and KIMYRSA [4] Clinical Developments - CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric Hemodialysis populations, with plans to develop it as a catheter lock solution for other patient groups [5] - REZZAYO is currently approved for treating candidemia and invasive candidiasis in adults, with a Phase III study ongoing for prophylaxis of invasive fungal disease in patients undergoing allogeneic bone marrow transplantation, with topline results expected in Q2 2026 [5]

Core Insights - CorMedix (CRMD) acquired Melinta Therapeutics for $300 million in August 2025, diversifying its revenue base and reducing reliance on its primary product, DefenCath [1][12] - The acquisition added seven approved products to CRMD's portfolio, contributing $12.8 million to its revenue in Q3 2025 [2][12] - DefenCath, approved by the FDA in late 2023, generated $167.6 million in net sales during the first nine months of 2025 [3] Revenue and Growth Opportunities - The Melinta acquisition is expected to create near-term growth opportunities, particularly through Rezzayo, which targets a market exceeding $2 billion for antifungal prophylaxis [4] - CRMD raised its full-year 2025 pro forma net revenue guidance to $390-$410 million, up from a previous estimate of at least $375 million, reflecting strong momentum from DefenCath and early contributions from Melinta [5] Competitive Landscape - Despite strong adoption of DefenCath, competition from major players like Pfizer, Amphastar Pharmaceuticals, and others poses a risk to CRMD's market position [6][7] - These competitors have stronger pipelines and greater resources, which could challenge CorMedix's growth outlook [8] - If Pfizer or Amphastar expands into catheter-related infection prevention, CRMD may face significant competitive pressure [10] Stock Performance and Valuation - CRMD shares have decreased by 2.5% over the past six months, underperforming the industry, which has rallied by 26.8% [13] - The stock is trading at a discount to the industry, with a price/book ratio of 2.55 compared to the industry average of 3.68 [14] - Earnings estimates for 2025 have improved from $1.85 to $2.87 per share, and for 2026 from $2.49 to $2.88 [15]

Core Insights - CorMedix Inc. is addressing a significant unmet medical need in preventing dialysis-related bloodstream infections through its catheter lock solution, DefenCath, which has shown promising clinical results [2][3] Group 1: Product Development and Clinical Results - DefenCath has demonstrated a 72% reduction in catheter-related bloodstream infections and a 70% reduction in related hospitalizations based on real-world evidence from a study ongoing since mid-2024 [3] - The adoption of DefenCath is exceeding expectations, with utilization rates well above the target of 6,000 patients [4] Group 2: Financial Performance and Growth Opportunities - CorMedix reported approximately $13 million in sales from Melinta Therapeutics' portfolio in September, indicating potential for significant synergies and growth opportunities outside the hemodialysis space [5] - The company is finalizing supply pricing under existing contracts and aims to boost utilization among Medicare Advantage users in the upcoming months [5] Group 3: Future Prospects - CorMedix is preparing for add-on periods beginning in summer 2026 and anticipates Phase III trial data for its other leading candidate, REZZAYO, in early 2026 [6]