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 (NASDAQ: CRMD) has received supportive feedback from the FDA regarding its plans to expand the use of DefenCath to adult Total Parenteral Nutrition (TPN) patients. The company plans to submit a complete clinical protocol by the third quarter of 2024 and aims to start the program by year-end. The FDA also requires a pediatric study under the Pediatric Research Equity Act. An independent market assessment shows a critical unmet need for DefenCath in TPN patients, with an estimated CLABSI rate over 25% and an addressable market of 5 million yearly infusions. Further details will be shared in CorMedix's Q2 earnings call in August.
CorMedix announced that CMS has granted pass-through status to DefenCath under the Out-Patient Prospective Payment System (OPPS). This status allows for separate Medicare Part B payments for DefenCath for at least two years, and up to three years, in outpatient settings. DefenCath, a combination of taurolidine and heparin, is used to reduce catheter-related bloodstream infections (CRBSI) in chronic hemodialysis patients using central venous catheters. The company estimates around 100,000 HD-CVC placements annually, highlighting the importance of reimbursement for DefenCath to prevent CRBSIs. However, DefenCath is contraindicated in patients with heparin-induced thrombocytopenia or hypersensitivity to any of its components.
CorMedix (Nasdaq: CRMD) announced a multi-year commercial supply contract with a top-tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin). Approved under the LPAD pathway on November 15, 2023, DefenCath® started commercialization in inpatient settings on April 15 and will begin in outpatient dialysis clinics in July. The agreement covers over 500 dialysis facilities, providing thousands of patients access to the infection-reducing product. CEO Joseph Todisco emphasized the importance of broad patient access and the company's commitment to innovation and infection reduction.
CorMedix Inc. (Nasdaq: CRMD) is set to participate in two upcoming investor conferences, the JMP Securities Life Sciences Conference on May 13-14, 2024, and the RBC Capital Markets Global Healthcare Conference on May 14-15, 2024. Management will engage in fireside chats and investor meetings during these events, with details provided for each. The events will be webcasted, and replays will be available on the company's investor relations website.
CorMedix Inc. reported financial results for Q1 2024, highlighting a net loss of $14.5 million. The company successfully launched DefenCath® and secured a commercial supply contract with ARC Dialysis. CMS approved a new HCPCS code for DefenCath, qualifying for TDAPA. The FDA granted a Type C meeting to discuss development plans. The company remains financially stable with $58.6 million in cash and short-term investments.
CorMedix Inc. (Nasdaq: CRMD) will report its financial results for the first quarter of 2024 on May 9, 2024. The company focuses on developing therapeutic products for life-threatening diseases. A corporate update conference call will follow the release.
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