CorMedix Inc. to Report First Quarter 2021 Financial Results and Provide a Corporate Update on May 13
CorMedix announced it will report its Q1 2021 financial results on May 13, after the market close, followed by a conference call at 4:30 PM ET. The company is focused on developing its lead product, DefenCath, designed to prevent bloodstream infections in hemodialysis patients. DefenCath is recognized as a Fast Track product by the FDA, with additional marketing exclusivity provided by its QIDP designation. The company also aims to expand the use of DefenCath and leverage its taurolidine technology for other antimicrobial devices.
- DefenCath designated by FDA as Fast Track and QIDP, granting extra marketing exclusivity.
- Plans for pediatric clinical study will add six months of marketing exclusivity upon NDA approval.
- DefenCath has potential for use in oncology and total parenteral nutrition patients.
- Received Complete Response Letter from FDA, delaying NDA approval due to manufacturing deficiencies.
BERKELEY HEIGHTS, N.J., May 05, 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 first quarter ended March 31, 2021, after the market close on Thursday, May 13, and will host a corporate update conference call at 4:30pm Eastern Time.
| Thursday, May 13th @ 4:30pm ET | |
| Domestic: | 877-423-9813 |
| International: | 201-689-8573 |
| Conference ID: | 13718937 |
| 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 financial results for Q1 2021?
What is DefenCath and its significance for CorMedix?
What does the Complete Response Letter from the FDA mean for CorMedix?
