CorMedix Inc. to Report Second Quarter 2021 Financial Results and Provide a Corporate Update on August 12
CorMedix Inc. (Nasdaq: CRMD) will announce its second-quarter financial results on August 12, 2021, following market close, and hold a conference call at 4:30 PM ET. The company is focused on its lead product, DefenCath™, which aims to prevent infections in patients with central venous catheters during hemodialysis. DefenCath has received Fast Track designation and was granted a Qualified Infectious Disease Product status by the FDA, allowing for additional marketing exclusivity upon NDA approval. Investors may gain insights into upcoming clinical studies and financial outlook during the call.
- DefenCath™ is designated as a QIDP, offering potential five years of marketing exclusivity.
- The product also received Fast Track designation from the FDA.
- CorMedix is committed to conducting a pediatric clinical study, which could extend marketing exclusivity by six months.
- Received a Complete Response Letter from the FDA indicating unresolved deficiencies at the contract manufacturing facility.
BERKELEY HEIGHTS, N.J., July 28, 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 second quarter ended June 30, 2021, after the market close on Thursday, August 12, 2021, and will host a corporate update conference call at 4:30pm Eastern Time.
| Thursday, August 12th @ 4:30pm ET | |||
| Domestic: | 877-423-9813 | ||
| International: | 201-689-8573 | ||
| Conference ID: | 13721575 | ||
| 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 Q2 2021?
What is DefenCath™ and its significance for CorMedix?
What is the impact of the Complete Response Letter from the FDA on CorMedix?
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