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Cormedix Inc. To Present At The Jefferies Healthcare Conference

Key Takeaway: Cormedix Inc. will present at the upcoming Jefferies Healthcare Conference, focusing on its lead product, DefenCath. This novel antimicrobial solution aims to prevent bloodstream infections in hemodialysis patients and has been granted Fast Track designation by the FDA. Despite recent regulatory hurdles, including a second Complete Response Letter from the FDA, CorMedix continues to pursue its NDA resubmission and intends to expand DefenCath's indications. The company also plans to explore taurolidine-based therapies for rare pediatric cancers.

Market Sentiment Analysis

POSITIVE FACTORS

  • Cormedix is presenting at the Jefferies Healthcare Conference, highlighting investor interest.
  • DefenCath has received Fast Track designation and potential for extended market exclusivity.
  • The company is committed to conducting a clinical study for pediatric patients, showcasing future growth opportunities.

CONCERNS & RISKS

  • Received a second Complete Response Letter from the FDA due to manufacturing deficiencies.
  • Ongoing challenges related to the NDA process could delay product availability.

Full Press Release Details

BERKELEY HEIGHTS, N.J., May 30, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be presenting and participating in investor meetings at the Jefferies Healthcare Conference being held in New York on June 7 – 9, 2023.
Jefferies Healthcare Conference
Date: Thursday, June 8, 2023
Time: 11:30am EDT
Webcast: Click here
A replay of the presentation will also be available in the “Events and Presentations” page on the investor relations portion of the Company’s website at: www.cormedix.com
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, non-antibiotic antimicrobial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed.   The Company received a second Complete Response Letter from the FDA last August related to deficiencies at both its primary contract manufacturer and its supplier of heparin API. The Company conducted a Type A meeting with FDA in April of 2023 and resubmitted the NDA for DefenCath in May of 2023. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information visit: www.cormedix.com.

Frequently Asked Questions

What is CorMedix Inc. focused on?

CorMedix Inc. develops therapeutic products for life-threatening conditions.

When is CorMedix presenting at the Jefferies Conference?

CorMedix will present on June 8, 2023, at 11:30am EDT.

What is DefenCath™ designed for?

DefenCath™ prevents bloodstream infections from central venous catheters.

What designations has DefenCath received from the FDA?

DefenCath has Fast Track and QIDP designations from the FDA.

What clinical study will CorMedix conduct after NDA approval?

CorMedix plans a study in pediatric patients using central venous catheters.

Last updated: May 30, 2023