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 ...

BERKELEY HEIGHTS, N.J., Jan. 29, 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 that it will host an in-person and virtual analyst day in New York on Tuesday, February 10, 2026 with presentations and panels from 1:00 PM to 3:00 PM Eastern. The Company will share background and updates across its portfolio and pipeline, and outline the busine ...

Key Takeaways CRMD's primary revenue driver, DefenCath, posted $167.6M in sales in the first nine months of 2025.CRMD guided 2026 revenues in the range of $300-$320M, with DefenCath sales expected to be $150-$170 million.CRMD's outlook is clouded by cautious guidance, pricing headwinds and high reliance on DefenCath.CorMedix (CRMD) has been riding on the success of its lead product, DefenCath (taurolidine plus heparin), which was approved by the FDA in 2023 as the first and only antimicrobial catheter lock ...

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]

New York, New York--(Newsfile Corp. - January 14, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into CorMedix Inc. ("CorMedix Inc.") (NASDAQ: CRMD) concerning potential violations of the federal securities laws.On January 8, 2026, before the market opened, CorMedix published preliminary fourth quarter and full year 2025 results disclosing that its major revenue driver DefenCath would change its reimbursement policy change beginning on July 1, 2026.Management noted that ...

Company Overview - CorMedix Therapeutics is a diversified specialty pharmaceutical company focused on institutional settings of care, primarily offering injectable drugs used in hospitals and infusion centers [3] - The company has a strong financial profile with approximately $150 million in cash and close to zero net debt [3] Financial Projections - Revenue guidance for 2026 is projected to exceed $300 million, with EBITDA expected to be between $100 million and $125 million [3] - The company anticipates increasing its cash position throughout the year [3] Commercial Strategy - CorMedix has a scalable platform supported by a solid commercial team experienced across multiple therapeutic areas [4]

CorMedix FY Conference Summary Company Overview - **Company**: CorMedix (NasdaqGM:CRMD) - **Industry**: Specialty Pharmaceuticals - **Focus**: Institutional settings of care, primarily injectable drugs used in hospitals and infusion centers [2][3] Financial Highlights - **Cash Position**: Approximately $150 million cash on hand, close to zero net debt [2][6] - **Revenue Guidance for 2026**: Expected to exceed $300 million, with EBITDA between $100-$125 million [3][5] - **2025 Revenue**: Exceeded $400 million, driven by DefendCath and Melinta acquisition [5][6] Key Products and Pipeline DefendCath - **Approval**: Approved in late 2023, launched mid-2024 [6][8] - **Indication**: Reduces risk of catheter-related bloodstream infections (CRBSIs) in hemodialysis patients [8][9] - **Market Size**: Total addressable market (TAM) of approximately $750 million [23] - **Reimbursement**: Under CMS's TDAPA, transitioning to post-TDAPA add-on period in July 2026 [10][11] - **Clinical Impact**: Phase 3 study showed a 71% reduction in CRBSI risk; real-world data from US Renal Care showed a 70% reduction in hospitalizations [12][13] Rezzayo - **Current Status**: In phase three clinical studies for prophylaxis of fungal infections in immunocompromised patients, with results expected in Q2 2026 [3][14] - **Market Potential**: TAM over $2 billion for prophylaxis of invasive fungal infections [21] Leadership and Team - **New Additions**: Mike Seckler as Chief Commercial Officer and Susan Blum as CFO, enhancing the leadership team [4] Strategic Initiatives - **Acquisition of Melinta**: Added $140 million in revenue and a portfolio of anti-infectious products [5][16] - **Future Growth**: Focus on expanding indications for existing products and pursuing strategic tuck-in business development [17][23] Market Position and Valuation - **Current Valuation**: Trading at a significant discount compared to peers (5x EBITDA vs. 12x for peers) [27] - **Investor Education**: Emphasis on improving communication regarding the value of Rezzayo and DefendCath for TPN [27][28] Upcoming Milestones - **Analyst Day**: Scheduled for February 10, 2026, to discuss growth trajectory and upcoming catalysts [24] - **Clinical Data Updates**: Expected for TPN study and Rezzayo sNDA submission in early 2027 [24][35] Regulatory and Competitive Landscape - **Legislative Risks**: Potential changes in TDAPA reimbursement structure could impact future revenue [35] - **Intellectual Property**: Strong IP protection for DefendCath and Rezzayo, with exclusivity extending into the 2030s [38][39] Conclusion - **Outlook**: CorMedix is positioned as a robust, diversified specialty pharmaceutical company with a strong financial profile and significant growth potential through its product pipeline and strategic initiatives [26]