CorMedix Inc. to Report Fourth Quarter and Fiscal Year 2021 Financial Results and Provide a Corporate Update on March 29
CorMedix Inc. (Nasdaq: CRMD) will report its financial results for the fourth quarter and full year ending December 31, 2021, post-market on March 29, 2022. The company focuses on developing therapeutic products for infectious and inflammatory diseases, notably its lead product DefenCath, designed to prevent bloodstream infections in hemodialysis patients. DefenCath has Fast Track and QIDP designations from the FDA, which offer extended marketing exclusivity. The NDA submission has faced issues but has been resubmitted addressing manufacturing deficiencies.
- DefenCath has Fast Track and QIDP designations from the FDA, offering extended marketing exclusivity.
- The resubmitted NDA addresses previous manufacturing deficiencies, moving the approval process forward.
- The FDA issued a Complete Response Letter citing deficiencies at the contract manufacturing facility, delaying the NDA approval.
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BERKELEY HEIGHTS, N.J., March 22, 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 fourth quarter and year ended December 31, 2021, after the market close on Tuesday, March 29, 2022, and will host a corporate update conference call at 4:30pm Eastern Time.
| Tuesday, March 29th @ 4:30pm ET | ||
| Domestic: | 1-877-423-9813 | |
| International: | 1-201-689-8573 | |
| Conference ID: | 13727363 | |
| 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 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. The deficiencies have been addressed in the resubmitted NDA which is being reviewed by FDA for acceptance for filing. 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
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