CorMedix Inc. to Report Third Quarter 2021 Financial Results and Provide a Corporate Update on November 9
CorMedix Inc. (CRMD) announced it will report its Q3 financial results on November 9, 2021, following the market close. The company specializes in developing therapeutic products for infectious and inflammatory diseases, with a focus on its lead product, DefenCath. This product aims to prevent bloodstream infections related to central venous catheters in chronic hemodialysis patients. DefenCath has received FDA Fast Track designation and QIDP status for marketing exclusivity. However, the company also noted it received a Complete Response Letter from the FDA due to deficiencies at its manufacturing facility.
- DefenCath received FDA Fast Track and Qualified Infectious Disease Product designations.
- The NDA for DefenCath has priority review status, indicating its potential to meet an unmet medical need.
- Potential additional marketing exclusivity of six months for pediatric clinical study post-NDA approval.
- Received a Complete Response Letter from the FDA, delaying NDA approval due to manufacturing deficiencies.
BERKELEY HEIGHTS, N.J., Nov. 02, 2021 (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 third quarter ended September 30, 2021, after the market close on Tuesday, November 9, 2021, and will host a corporate update conference call at 4:30pm Eastern Time.
| Tuesday, November 9th @ 4:30pm ET | |
| Domestic: | 877-423-9813 |
| International: | 201-689-8573 |
| Conference ID: | 13723602 |
| 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 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. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. 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
When will CorMedix report its Q3 financial results in 2021?
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What is the significance of the Complete Response Letter for CorMedix?
