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 ...

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].

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]