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CorMedix Inc. - CRMD STOCK NEWS

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. (Nasdaq: CRMD), headquartered in Bridgewater, NJ, is a biopharmaceutical company dedicated to the development and commercialization of therapeutic products aimed at preventing and treating infectious and inflammatory diseases. The company's flagship product, DefenCath®, is targeted towards reducing the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure undergoing chronic hemodialysis through a central venous catheter.

Recently, CorMedix announced its financial results for the fourth quarter and full year ended December 31, 2023, during a conference call held on March 12, 2024. The company showcased significant advancements in their product pipeline and continued efforts to expand the market reach of DefenCath®. This includes ongoing clinical trials and strategic partnerships aimed at enhancing patient safety and treatment efficacy.

DefenCath®, which combines taurolidine and heparin, has been pivotal in addressing the critical need for infection control in hemodialysis patients. The product has shown promising results in reducing bloodstream infections and is poised to make a substantial impact in the healthcare sector. CorMedix remains committed to research and development, with an emphasis on innovation and quality.

For more detailed information about DefenCath®, including safety information, prescribing guidelines, and potential adverse effects, professionals and patients are encouraged to review the full prescribing information available on the company's website.

CorMedix's financial health remains robust, bolstered by strategic investments and a clear focus on growth and sustainability. The company continues to engage with investors and stakeholders through transparent communication and regular updates on their progress.

For latest updates and detailed news about CorMedix Inc., investors and interested parties can visit the company's website and review recent press releases and financial reports.

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CorMedix Inc. (Nasdaq: CRMD) has announced the commercialization of DefenCath® (taurolidine and heparin) for outpatient dialysis centers and vascular access clinics. This launch, effective from July 1st, aligns with the Centers for Medicare & Medicaid Services (CMS) reimbursement for outpatient use.

DefenCath, approved by the FDA under the Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, initially launched for inpatient settings on April 15, 2024. The product is designed to reduce catheter-related bloodstream infections (CRBSI) in adults undergoing chronic hemodialysis through a central venous catheter.

CorMedix has begun shipping orders to dialysis operators, with additional customer agreements expected soon. The CEO, Joseph Todisco, expressed optimism about expanding access and the effective rollout by customers.

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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.

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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.

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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.

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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.

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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.

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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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CorMedix Inc. announced that CMS granted TDAPA to DefenCath, a critical step for the company's outpatient launch in July 2024. DefenCath is approved by the FDA to reduce CRBSIs in adult patients with kidney failure.
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CorMedix Inc. announces the U.S. inpatient commercial availability of DefenCath (Taurolidine and Heparin), a solution to reduce catheter-related bloodstream infections in adult patients with kidney failure. The company plans to expand to outpatient settings by July 1, 2024, pending CMS approval.
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CorMedix Inc. (CRMD) announces acceptance of two abstracts for presentation at the SHEA conference. The first abstract showcases taurolidine's broad antimicrobial activity against various bacteria, including NTM and fungal isolates. The second abstract highlights outcomes and economics of hospital-acquired bloodstream infections in hemodialysis patients.
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FAQ

What does CorMedix Inc. specialize in?

CorMedix Inc. specializes in developing and commercializing therapeutic products to prevent and treat infectious and inflammatory diseases.

What is DefenCath®?

DefenCath® is a product aimed at reducing catheter-related bloodstream infections in hemodialysis patients using a central venous catheter.

Where is CorMedix Inc. headquartered?

CorMedix Inc. is headquartered at 745 Route 202-206, Suite 303, Bridgewater, NJ, United States.

How did CorMedix Inc. perform in the fourth quarter of 2023?

CorMedix Inc. announced positive financial results for the fourth quarter and full year ended December 31, 2023, highlighting significant advancements and continued growth.

Who can use DefenCath®?

DefenCath® is indicated for adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter to reduce the incidence of catheter-related bloodstream infections.

What are the potential side effects of DefenCath®?

Common side effects include hemodialysis catheter malfunction, hemorrhage, bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

How can safety concerns about DefenCath® be reported?

Safety concerns can be reported to CorMedix Inc. at 1-888-424-6345 or to the FDA at 1-800-FDA-1088 or through the FDA's MedWatch website.

What recent events did CorMedix Inc. announce?

CorMedix recently announced financial results for the fourth quarter and full year ended December 31, 2023, and provided updates on their business and product pipeline during a conference call on March 12, 2024.

Who is the investor contact for CorMedix Inc.?

The investor contact is Dan Ferry, Managing Director at LifeSci Advisors. He can be reached at (617) 430-7576 or via email at daniel@lifesciadvisors.com.

Where can I find more detailed information about DefenCath®?

Detailed information about DefenCath®, including prescribing guidelines and safety information, can be found on the CorMedix website.

CorMedix Inc.

Nasdaq:CRMD

CRMD Rankings

CRMD Stock Data

249.79M
54.96M
0.96%
31.63%
18.13%
Pharmaceutical Preparation Manufacturing
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United States of America
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