CorMedix Inc.

CorMedix Inc. has secured a significant legal victory as the U.S. Court of Appeals for the Federal Circuit affirmed a lower court's judgment. The ruling confirms that Nexus Pharmaceuticals Inc.'s generic minocycline product infringes two of CorMedix's patents and rejects Nexus's challenge to the patents' validity. This decision upholds a permanent injunction against Nexus, preventing them from marketing their generic product until patent expiration, and validates the intellectual property protecting CorMedix's MINOCIN® for Injection.

CorMedix announced that the U.S. Court of Appeals for the Federal Circuit affirmed the validity and infringement of its MINOCIN® for Injection patents by Nexus Pharmaceuticals, Inc. This decision upholds a prior district court ruling from 2023 and rejects Nexus' invalidity challenge. The Federal Circuit also affirmed a permanent injunction, preventing Nexus from marketing its generic minocycline product before patent expiration, thereby protecting CorMedix's innovative intravenous minocycline therapy.

CorMedix Therapeutics announced that its management will participate in two upcoming investor conferences. The company will attend the RBC Capital Markets Global Healthcare Conference on May 19-20, 2026, and the Jefferies Global Healthcare Conference on June 2-4, 2026. Fireside chats are scheduled for May 20 at 11:00 am EDT and June 3 at 4:20 pm EDT, respectively, with webcasts available for both events.

CorMedix Inc. reported a significant increase in total revenue to $127.4 million for Q1 2026, up from $39.1 million in Q1 2025, primarily driven by the Melinta Therapeutics acquisition in August 2025. Net income also rose to $38.6 million, or $0.43 diluted EPS, compared to $20.6 million, or $0.30 diluted EPS, in the prior year. The company also announced positive Phase III topline results for REZZAYO for prophylaxis of invasive fungal diseases, targeting commercialization in 2027. Additionally, a change in accounting estimates positively impacted net sales by $9.0 million and net income by $6.2 million.

CorMedix reported strong first quarter 2026 financial results, with net revenue of $127.4 million and net income of $38.6 million, significantly increasing from the prior year. The company also raised its full-year 2026 net revenue and adjusted EBITDA guidance, reflecting robust performance driven by DefenCath sales and contributions from the Melinta portfolio. Additionally, CorMedix announced positive Phase III topline results for REZZAYO and is advancing its pipeline, while maintaining a strong cash position.

CorMedix Therapeutics announced it will report its financial results for the first quarter ended March 31, 2026, before the market opens on Thursday, May 14, 2026. The company will also host a corporate update conference call at 8:30 AM Eastern Time on the same day to discuss the results and provide a corporate update.

CorMedix Inc. announced its 2026 Annual Meeting of Stockholders for June 23, 2026, where shareholders will vote on key proposals including director elections, auditor ratification, and several corporate governance amendments. The company reported a transformational 2025, achieving $311.7 million in total revenue and $163.0 million in net income, significantly up from a net loss in 2024, driven by DefenCath sales and the acquisition of Melinta Therapeutics. The proposed governance changes aim to streamline operations, align voting rights, and enhance officer protections.

CorMedix Inc. announced positive topline results from its global Phase III ReSPECT clinical trial evaluating REZZAYO® (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation. The study met its primary endpoint, demonstrating non-inferiority against standard antimicrobial regimens with 60.7% fungal-free survival at Day 90 for rezafungin versus 59.0% for the standard regimen. Rezafungin was well tolerated, showing a favorable safety profile and reduced drug-drug interactions, positioning it as a potential alternative if approved for an expanded indication. The company plans a pre-NDA meeting with the FDA soon, targeting a supplemental New Drug Application submission in the second half of 2026.

CorMedix Inc. announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation. The study met its primary endpoint, demonstrating non-inferiority in fungal-free survival at Day 90 compared to standard antimicrobial regimens (60.7% vs. 59.0%). Rezafungin was well tolerated with a favorable safety profile, particularly regarding toxicity-related discontinuations and drug-drug interactions. The company plans a pre-NDA meeting with the FDA in the coming months, targeting a supplemental New Drug Application (sNDA) submission in 2H26 for an expanded prophylaxis indication, with an estimated US market opportunity exceeding $2 billion.