CorMedix Inc. To Report Second Quarter 2022 Financial Results and Provide a Corporate Update on August 11
CorMedix Inc. (Nasdaq: CRMD) announced it will report its financial results for Q2 2022 on August 11, 2022, before market open. A conference call will follow at 8:30 AM ET. The company focuses on developing therapeutic products for infectious and inflammatory diseases, particularly its lead product, DefenCath™, aimed at preventing bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and Qualified Infectious Disease Product designations from the FDA, which may enhance market exclusivity upon approval.
- DefenCath designated as Fast Track and Qualified Infectious Disease Product by FDA.
- Potential for additional five years of marketing exclusivity upon NDA approval.
- Commitment to conduct pediatric clinical studies post-NDA approval for further exclusivity.
- Received Complete Response Letter from FDA regarding the original NDA.
BERKELEY HEIGHTS, N.J., Aug. 01, 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 it will report its financial results for the second quarter ended June 30, 2022, before the market open on Thursday, August 11, 2022, and will host a corporate update conference call at 8:30am Eastern Time.
| Thursday, August 11th @ 8:30am ET | |
| Domestic: | 1-877-423-9813 |
| International: | 1-201-689-8573 |
| Conference ID: | 13730940 |
| Webcast: | 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 the anticipated approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis if the NDA is approved, which will add an additional six months of marketing exclusivity once the study is completed. The company received a Complete Response Letter from FDA for the original NDA and we believe the deficiencies have been addressed in the resubmitted NDA that is under review by FDA. 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 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
daniel@lifesciadvisors.com
(617) 430-7576
FAQ
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