CorMedix completes enrollment in phase III fungal infection study

BERKELEY HEIGHTS, N.J. - CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company with a market capitalization of $882 million and impressive gross profit margins of 96%, announced on Monday it has completed enrollment for its Phase III ReSPECT trial evaluating REZZAYO (rezafungin) for the prevention of fungal infections in patients undergoing allogeneic blood and marrow transplantation. According to InvestingPro analysis, the company maintains strong financial health with a "GREAT" overall score, suggesting solid operational execution.

The global study is examining the efficacy of once-weekly rezafungin compared to a standard antimicrobial regimen for preventing invasive fungal diseases. Topline results are expected in the second quarter of 2026, according to the company’s press release. With analysts projecting significant revenue growth of 485% for fiscal year 2025 and price targets ranging from $17 to $23, the market appears optimistic about the trial’s potential impact.

"Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT," said Joseph Todisco, CEO of CorMedix.

The ReSPECT trial is a multicenter, randomized, double-blind study where participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks. The primary endpoint is fungal-free survival at day 90.

REZZAYO is currently approved in the United States for treating candidemia and invasive candidiasis in adults. The company estimates there are approximately 130,000 patients who could constitute the addressable market for antifungal prophylaxis in the U.S.

CorMedix, which recently acquired Melinta Therapeutics in August 2025, is a biopharmaceutical company focused on developing and commercializing therapeutic products for preventing and treating life-threatening conditions. The company’s portfolio includes several anti-infective products.

The ReSPECT clinical trial is being sponsored by Mundipharma, located in the United Kingdom. The U.S. distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, a wholly owned subsidiary of CorMedix. Trading at $11.30, InvestingPro analysis suggests the stock is currently undervalued, with additional insights available in the comprehensive Pro Research Report, which provides deep-dive analysis of CorMedix among 1,400+ top US stocks.

In other recent news, CorMedix Inc. has announced several significant developments. The company completed a $150 million convertible notes offering, which was conducted through a private placement and is set to mature in 2030. Additionally, CorMedix revealed plans to acquire Melinta Therapeutics LLC for $300 million, a move that will expand its commercial portfolio with seven additional drug products. The acquisition agreement includes a $260 million cash payment and $40 million in equity, with potential milestone payments and royalties on certain products.

In a strategic move, CorMedix also led a $29 million financing round for Talphera, Inc., securing a right of first negotiation to acquire Talphera after Phase 3 results for its lead candidate, Niyad, are announced. Meanwhile, JMP Securities has reiterated its Market Outperform rating for CorMedix, maintaining a price target of $22.00. However, D. Boral Capital downgraded CorMedix from Buy to Hold, following the company’s announcement of a public offering expected to raise approximately $85 million. These recent developments highlight CorMedix’s active engagement in strategic investments and acquisitions.

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