Business
CorMedix Inc. Reports First Quarter 2023 Financial Results and Provides Business Update
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time BERKELEY HEIGHTS, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: 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 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2023 and provided an update on recent business developments. Recent Corporate Highlights: As previously guided, CorMedix is resubmitting its DefenCath New Drug Application, or NDA, to the U.S. Food and Drug Administration (“FDA”). The Company anticipates that the NDA will be classified as a Type 2 resubmission with a 6-month review cycle with a target action date in November.The Company also recently announced that the US Patent & Trademark office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly allowed U.S. Patent Application reflects the unique and proprietary nature of DefenCath, and will extend our current intellectual property protection to an anticipated expiration date in 2042.CorMedix recently announced that following our submission of a duplicate New Technology Add-On Payment, or NTAP, application to the Centers for Medicare & Medicaid Services, CMS has issued the Inpatient Prospective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024. Cash and short-term investments, excluding restricted cash, at March 31, 2023 amounted to $55.6 million. Joe Todisco, CorMedix CEO, commented, “we are excited to announce today that our DefenCath NDA is ready to be resubmitted to FDA. The resubmission reflects the hard work of the CorMedix regulatory and technical teams and our strategic partners, and we will now increase our focus on preparations for a potential commercial launch in early 2024. We look forward to providing additional updates as we progress toward potential approval in 2023 and aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous catheters.” First Quarter 2023 Financial Highli...