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CorMedix Inc. to Present at the H.C. Wainwright Annual Global Investment Conference

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CorMedix Inc. (CRMD) announced its participation at the H.C. Wainwright Annual Global Investment Conference in New York from September 12-14, 2022. The company's presentation will take place on September 12 at 12:30 PM EDT. CorMedix focuses on developing therapeutic products to combat infectious and inflammatory diseases, including its lead product DefenCath, which aims to prevent bloodstream infections associated with central venous catheters in patients on hemodialysis. The FDA has designated DefenCath as Fast Track and QIDP, recognizing its potential to address unmet medical needs.

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BERKELEY HEIGHTS, N.J., Sept. 07, 2022 (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 management will be presenting a corporate overview at the H.C. Wainwright Annual Global Investment Conference being held in New York on September 12 – 14, 2022.

H.C. Wainwright Annual Global Investment Conference

Date:        Monday, September 12, 2022
Time:        12:30pm EDT
Webcast Link

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 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 Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved. FDA notified the Company in a second CRL that the refiled NDA could not be approved until satisfactory resolution of deficiencies identified during a pre-approval inspection at the CMO and during an inspection for an unrelated active pharmaceutical ingredient at the manufacturing facility for the heparin supplier for DefenCath. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with plans for 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

When is CorMedix presenting at the H.C. Wainwright Annual Global Investment Conference?

CorMedix is presenting on September 12, 2022, at 12:30 PM EDT.

What is DefenCath and its significance in the market?

DefenCath is CorMedix's lead product designed to prevent bloodstream infections in patients undergoing chronic hemodialysis.

What are the designations received by DefenCath from the FDA?

DefenCath has received Fast Track designation and is classified as a Qualified Infectious Disease Product (QIDP) by the FDA.

What challenges has CorMedix faced with the FDA regarding DefenCath?

CorMedix received Complete Response Letters (CRLs) indicating that the NDA could not be approved until deficiencies at the contract manufacturing organization were resolved.

What additional studies is CorMedix planning for DefenCath?

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

CorMedix Inc.

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Biotechnology
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BERKELEY HEIGHTS