Welcome to our dedicated page for Cormedix news (Ticker: CRMD), a resource for investors and traders seeking the latest updates and insights on Cormedix stock.
Cormedix Inc (CRMD) is a clinical-stage biopharmaceutical company pioneering novel therapies for life-threatening infectious and inflammatory conditions. This news hub provides investors and healthcare stakeholders with essential updates on DefenCath developments, regulatory milestones, and therapeutic pipeline progress.
Access timely announcements including FDA correspondence, clinical trial data, and commercialization strategies for CRMD's catheter lock solutions. Our curated collection features earnings reports, partnership disclosures, and scientific presentations relevant to infection prevention in critical care settings.
Key updates cover therapeutic candidate advancements, intellectual property developments, and market expansion initiatives. Monitor progress in addressing bloodstream infections through CRMD's specialized antimicrobial formulations designed for high-risk patient populations.
Bookmark this page for structured access to verified corporate communications and analysis of how CRMD navigates the complex biopharmaceutical regulatory landscape. Stay informed on developments impacting both patient care standards and long-term therapeutic innovation.
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.
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