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. has completed enrollment for the Phase III ReSPECT trial, which evaluates the efficacy of REZZAYO® (rezafungin) in preventing fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (BMT) [1][2] - Topline results from the ReSPECT study are expected in the second quarter of 2026, which is a significant milestone towards seeking FDA approval for REZZAYO in this indication [2][5] - The ReSPECT trial is a multicenter, randomized, double-blind study comparing once-weekly rezafungin to a standard antimicrobial regimen, with the primary endpoint being fungal-free survival at day 90 [2][3] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, including antifungal treatments [4] - Following the acquisition of Melinta Therapeutics in August 2025, CorMedix is expanding its portfolio to include various anti-infective products alongside REZZAYO [4][5] - REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis, with an estimated addressable market of approximately 130,000 patients for antifungal prophylaxis, translating to a total addressable market of over $2 billion [3][4] Product Details - REZZAYO (rezafungin) is a next-generation echinocandin indicated for patients with limited treatment options for candidemia and invasive candidiasis [3][7] - The drug has orphan drug exclusivity until 2035 and patent coverage until 2038 in the U.S., enhancing its market potential [3]