Cormedix Inc. to Report Fourth Quarter and Fiscal Year 2022 Financial Results and Provide a Corporate Update on March 30, 2023
CorMedix Inc. (Nasdaq: CRMD) announced it will report its financial results for Q4 and year-end December 31, 2022, on March 30, 2023, before market opening. The company will also host a corporate update conference call at 8:30 AM ET. CorMedix focuses on developing therapeutic products, including its lead product DefenCath™, which aims to prevent bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and QIDP designations from the FDA, which could grant up to 10 years of marketing exclusivity upon approval. However, the company received Complete Response Letters (CRLs) due to deficiencies at its contract manufacturing organization, delaying NDA approval.
- DefenCath™ received Fast Track and QIDP designations, offering marketing exclusivity advantages.
- CorMedix aims to transfer technology to another CMO and qualify a new heparin supplier.
- Received Complete Response Letters (CRLs) from FDA delaying NDA approval until manufacturing deficiencies are resolved.
BERKELEY HEIGHTS, N.J., March 21, 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 it will report its financial results for the fourth quarter and year ended December 31, 2022, before the market opens on Thursday, March 30, 2023, and will host a corporate update conference call at 8:30am Eastern Time.
| Thursday, March 30 @ 8:30am ET | |
| Domestic: | 1-877-423-9813 |
| International: | 1-201-689-8573 |
| Conference ID: | 13736467 |
| 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. For more information visit: www.cormedix.com.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576
FAQ
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