CorMedix Inc. to Participate at the 7th Annual Truist Securities Life Sciences Summit

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical firm, announced participation in the 7th Annual Truist Securities Life Sciences Summit on May 4-5, 2021. The company focuses on developing products for infectious and inflammatory diseases, notably DefenCath™, an antibacterial solution aimed at preventing bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and QIDP designations from the FDA, providing potential marketing exclusivity. After a Complete Response Letter from the FDA regarding manufacturing deficiencies, CorMedix plans to further develop DefenCath for oncology patients and explore taurolidine technology in their pipeline.

BERKELEY HEIGHTS, N.J., April 28, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that CorMedix management will participate in investor meetings at the 7th Annual Truist Securities Life Sciences Summit taking place on May 4 – 5, 2021.

About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial 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 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 Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels.  The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device.  For more information, visit: www.cormedix.com.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
617-430-7576

FAQ

What is CorMedix Inc. participating in on May 4-5, 2021?

CorMedix Inc. is participating in the 7th Annual Truist Securities Life Sciences Summit.

What is the main product developed by CorMedix Inc.?

The main product developed by CorMedix Inc. is DefenCath™, designed to prevent bloodstream infections in hemodialysis patients.

What FDA designations has DefenCath received?

DefenCath has received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA.

What was the FDA's response to CorMedix's New Drug Application (NDA)?

The FDA issued a Complete Response Letter stating the NDA could not be approved until manufacturing deficiencies were resolved.

How is CorMedix developing DefenCath for pediatric patients?

CorMedix plans to conduct a clinical study in pediatric patients using central venous catheters for hemodialysis once the NDA is approved.