CorMedix Inc. to Report First Quarter 2022 Financial Results and Provide a Corporate Update on May 12
CorMedix Inc. (Nasdaq: CRMD) is set to report its Q1 financial results on May 12, 2022, after market close. The company, focused on developing therapeutic products for infectious diseases, is advancing its lead product, DefenCath™, designed to prevent bloodstream infections in hemodialysis patients. DefenCath has received FDA’s Fast Track and Qualified Infectious Disease Product designations. The company has addressed manufacturing deficiencies mentioned in a previous Complete Response Letter from the FDA regarding the New Drug Application (NDA) for DefenCath.
- DefenCath™ designated as Fast Track and QIDP by FDA.
- Received priority review for New Drug Application (NDA) by FDA.
- Additional five years of marketing exclusivity upon approval as a New Chemical Entity.
- Commited to conducting pediatric clinical study for additional exclusivity.
- Received Complete Response Letter from FDA regarding NDA approval due to manufacturing deficiencies.
BERKELEY HEIGHTS, N.J. , May 03, 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 first quarter ended March 31, 2022, after the market close on Thursday, May 12, 2022, and will host a corporate update conference call at 4:30pm Eastern Time.
| Thursday, May 12th @ 4:30pm ET | |
| Domestic: | 1-877-423-9813 |
| International: | 1-201-689-8573 |
| Conference ID: | 13729290 |
| 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 original NDA could not be approved until deficiencies at the contract manufacturing facility were satisfactorily resolved and we believe the deficiencies have been addressed in the resubmitted NDA that has been accepted for filing 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
When will CorMedix report its Q1 financial results for 2022?
What is the significance of DefenCath for CorMedix?
What are the FDA designations received by DefenCath?
What was the issue raised by the FDA regarding the NDA for DefenCath?
What future plans does CorMedix have for DefenCath?
