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CorMedix Inc. to Report Third Quarter 2022 Financial Results and Provide a Corporate Update on November 10

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CorMedix Inc. (Nasdaq: CRMD) will announce its financial results for Q3 2022 on November 10, 2022, before market open. A corporate update conference call is scheduled for 8:30 AM ET. The company is focused on its lead product, DefenCath™, designed to prevent bloodstream infections in patients undergoing hemodialysis. DefenCath has received FDA Fast Track and QIDP designations, but the company is facing delays due to unresolved deficiencies at its contract manufacturing organization. CorMedix is also developing other products and solutions, including taurolidine-based therapies.

Positive
  • DefenCath has received FDA Fast Track and Qualified Infectious Disease Product (QIDP) designations.
  • Potential for an additional five years of marketing exclusivity upon NDA approval.
  • Commitment to conduct a pediatric clinical study for DefenCath, adding six months of marketing exclusivity upon completion.
Negative
  • Received Complete Response Letters (CRLs) from FDA, delaying NDA approval until deficiencies at the CMO are resolved.
  • Problems identified during pre-approval inspections could hinder production timelines.

BERKELEY HEIGHTS, N.J. , Nov. 02, 2022 (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 it will report its financial results for the third quarter ended September 30, 2022, before the market open on Thursday, November 10, 2022, and will host a corporate update conference call at 8:30am Eastern Time.

Thursday, November 10th @ 8:30am ET

Domestic:1-877-423-9813  
International:1-201-689-8573  
Conference ID:13733378  
Webcast:Webcast Link

 
  

About CorMedix

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, 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 facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer the technology to an additional CMO and qualify an additional supplier of heparin. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and has been 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
daniel@lifesciadvisors.com
(617) 430-7576


FAQ

When will CorMedix report its Q3 2022 financial results?

CorMedix will report its Q3 2022 financial results on November 10, 2022.

What is the status of CorMedix's DefenCath product?

DefenCath has received FDA Fast Track and QIDP designations but is facing delays due to CRLs concerning manufacturing deficiencies.

What does QIDP designation mean for CorMedix?

QIDP designation provides for an additional five years of marketing exclusivity upon NDA approval.

Is CorMedix developing any products for pediatric patients?

Yes, CorMedix is committed to conducting a clinical study of DefenCath in pediatric patients when the NDA is approved.

CorMedix Inc.

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Biotechnology
Pharmaceutical Preparations
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United States of America
BERKELEY HEIGHTS