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CorMedix Inc. to Present at the Cantor Fitzgerald Global Healthcare Conference

Key Takeaway: CorMedix Inc. (Nasdaq: CRMD) is set to present at the Cantor Fitzgerald Global Healthcare Conference from September 26-28, 2023, showcasing its focus on therapeutic products. The company is particularly emphasizing DefenCath®, a non-antibiotic antimicrobial solution aimed at preventing bloodstream infections in hemodialysis patients. Although the FDA has accepted its New Drug Application for filing, CorMedix faces regulatory hurdles, including a second Complete Response Letter concerning deficiencies at its manufacturing partners. Nevertheless, the company continues to work on expanding the application of DefenCath and other innovative therapies.

Market Sentiment Analysis

POSITIVE FACTORS

  • CorMedix is presenting at a major healthcare conference, indicating visibility and engagement in the industry.
  • DefenCath has received FDA Fast Track designation, reflecting its potential to fulfill an unmet medical need.
  • The acceptance of the NDA for filing by FDA demonstrates progress in CorMedix's development efforts.

CONCERNS & RISKS

  • CorMedix received a second Complete Response Letter from the FDA, indicating ongoing regulatory challenges.
  • Deficiencies were noted at the primary contract manufacturer and supplier, which could delay production and approval.

Full Press Release Details

BERKELEY HEIGHTS, N.J., Sept. 26, 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 giving a company presentation at the Cantor Fitzgerald Global Healthcare Conference being held in New York City on September 26 – 28, 2023.
Cantor Fitzgerald Global Healthcare Conference
Date: Thursday, September 28, 2023
Time: 8:35 a.m. EDT
Webcast: Webcast Link
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 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. CorMedix 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. After receiving guidance from FDA at a Type A meeting in April of 2023, the NDA for DefenCath was resubmitted. In June of 2023, the resubmitted NDA was accepted for filing by the FDA. 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. specializes in developing therapeutic products for serious conditions.

When is CorMedix presenting at the conference?

They will present on Thursday, September 28, 2023, at 8:35 a.m. EDT.

What is DefenCath® designed to prevent?

DefenCath® aims to prevent bloodstream infections from central venous catheters.

What FDA designations does DefenCath® have?

DefenCath® has Fast Track and Qualified Infectious Disease Product designations.

What marketing exclusivity does DefenCath® receive?

DefenCath® is granted five years of exclusivity, plus potential extensions for studies.

Last updated: Sep 26, 2023