Business
CorMedix Inc. Reports First Quarter 2020 Financial Results and Provides Business Update
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time BERKELEY HEIGHTS, N.J., May 11, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a
About this update from Cormedix Inc.
[{"type":"text","content":"Conference Call Scheduled for Today at 4:30 p.m. Eastern Time\nBERKELEY HEIGHTS, N.J., May 11, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced financial results for the first quarter ended March 31, 2020 and provided an update on recent business events.\n Recent Business Highlights: CorMedix announced the appointment of Matt David, M.D. as the Company’s Chief Financial Officer. FDA has conditionally accepted the proposed proprietary name, Defencath™, for the Company’s lead product candidate, a novel, non-antibiotic antimicrobial solution designed to prevent bloodstream infections associated with the use of central venous catheters in hemodialysis patients. A final decision and formal acceptance of the proprietary name will be completed during the review of the New Drug Application (NDA), which has been granted rolling submission and review by the U.S. Food and Drug Administration (FDA). The name “Defencath” will be used in the U.S. and potentially other international markets, while the name “Neutrolin®” will continue to be used in Europe and other territories where the product is CE-marked and commercially distributed as a medical device. The Company is continuing its focus on preparing the required information in the NDA modules to ensure a complete submission and facilitate an efficient review by the FDA. CorMedix remains optimistic for a potential approval of the NDA in the second half of 2020, subject to possible delays that would prevent approval of the NDA. CorMedix was granted a Small Business Waiver by the FDA, exempting the Company from the need to pay the $2.9 million NDA filing fee. The fee was deposited with the FDA during the first quarter 2020 and was returned to the Company in April. The Company will host a call with Key Opinion Leaders (KOLs) on the potential of Defencath/Neutrolin for addressing antimicrobial resistance and catheter-related bloodstream infections (CRBSIs) on Tuesday, May 19th at 12pm Eastern Time. The call will feature three presentations by noted KOLs, who will discuss antimicrobial resistance, the current CRBSI landscape in patients with hemodialysis catheters, and Defencath’s/ Neutrolin's potential for...