CorMedix Inc. to Present at the 21st Annual Needham Virtual Healthcare Conference
CorMedix Inc. (Nasdaq: CRMD) announced a corporate overview presentation at the 21st Annual Needham Virtual Healthcare Conference scheduled for April 12, 2022, at 11:00am EDT. The company focuses on developing therapeutic products for infectious and inflammatory diseases, notably its lead product, DefenCath, aimed at preventing bloodstream infections in hemodialysis patients. DefenCath is recognized by the FDA with Fast Track and QIDP designations, enhancing its marketing exclusivity. A recent FDA Complete Response Letter regarding deficiencies has been addressed with a resubmitted NDA.
- None.
- None.
BERKELEY HEIGHTS, N.J., April 04, 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 management will be presenting a corporate overview at the 21st Annual Needham Virtual Healthcare Conference being held April 11 – 14, 2022.
21st Annual Needham Virtual Healthcare Conference
| Date: | Tuesday, April 12, 2022 |
| Time: | 11:00am EDT |
| 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 satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. 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
(617) 430-7576
FAQ
What is the date and time of CorMedix's presentation at the Needham Virtual Healthcare Conference?
What is DefenCath and its significance in the healthcare sector?
What designations has DefenCath received from the FDA?
What recent action did the FDA take regarding CorMedix's NDA for DefenCath?
How is CorMedix addressing FDA concerns regarding its NDA for DefenCath?
