CorMedix Inc. develops and commercializes therapeutic products for life-threatening conditions, with a U.S. commercial focus in institutional settings of care. Its recurring news centers on DefenCath, a taurolidine and heparin product used to prevent catheter-related bloodstream infections in adult hemodialysis patients with central venous catheters, and on the specialty pharmaceutical portfolio added through the completed Melinta Therapeutics acquisition.
Company updates also cover anti-infective and hospital-focused products such as MINOCIN for Injection, REZZAYO, VABOMERE, ORBACTIV, BAXDELA and KIMYRSA, as well as TOPROL-XL. News themes include operating and financial results, commercial execution, clinical and regulatory disclosures for expanded product uses, shareholder voting matters, governance updates, investor conference activity and capital actions such as share repurchase authorization.
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CorMedix Inc. (Nasdaq: CRMD) announced plans to resubmit its New Drug Application (NDA) for DefenCath by mid-May 2023 after a productive Type A meeting with the FDA. The resubmission will leverage data from its existing contract manufacturing organization and a new heparin source. The FDA may conduct a pre-approval inspection during the review process. Additionally, CorMedix received a proposed New Technology Add-On Payment (NTAP) from CMS, potentially offering up to $17,111 per hospital stay for DefenCath, contingent on FDA approval by July 1, 2024. The anticipated new manufacturing process includes a 3 mL single-dose vial option. CEO Joe Todisco expressed optimism regarding NDA resubmission and the product's potential in hemodialysis infection prevention.