CorMedix Inc. - CRMD STOCK NEWS

CorMedix Inc. (NYSE American: CRMD) announced that the FDA has canceled the scheduled Antimicrobial Drug Advisory Committee meeting for its New Drug Application (NDA) of Defencath®, aimed at preventing catheter-related infections in hemodialysis patients. The PDUFA date remains set for February 28, 2021, allowing continued dialogue with the FDA without the need for additional committee discussions. CorMedix is optimistic about bringing Defencath to market, noting its Fast Track and Qualified Infectious Disease Product designations, which could extend marketing exclusivity by five years.

CorMedix (NYSE American: CRMD) reported its Q3 2020 results, showing a net loss of $6.6 million, or $0.22 per share, compared to a $5.3 million loss in Q3 2019. For nine months, the loss totaled $15.9 million, up from $11.1 million year-over-year, primarily due to rising operational costs. R&D expenses increased by 16% in Q3, while SG&A expenses grew by 40%. The company continues preparations for the FDA meeting on Defencath™ scheduled for January 14, 2021. As of September 30, 2020, CorMedix reported $37 million in cash available for its operational needs.

CorMedix Inc. (CRMD) announced the appointment of Greg Duncan to its Board of Directors, effective immediately, as he replaces Dr. Mehmood Khan, who stepped down due to new commitments. Duncan brings extensive leadership experience from Pfizer and UCB, which is expected to aid CorMedix as it transitions to a commercial stage company focused on its lead product Defencath.

Defencath aims to prevent bloodstream infections in hemodialysis patients, with its New Drug Application (NDA) under priority review by the FDA, set for a decision by February 28, 2021.

CorMedix Inc. (NYSE American: CRMD) announced it will release its third-quarter financial results on November 5, 2020, after market close, followed by a conference call at 4:30 PM EST. The company is focused on developing its lead product, Defencath®, designed to prevent bloodstream infections in patients with central venous catheters. Defencath's New Drug Application (NDA) has been accepted for priority review by the FDA, with a PDUFA date set for February 28, 2021. Additionally, Defencath is designated as a Qualified Infectious Disease Product, potentially extending its marketing exclusivity.

CorMedix Inc. (NYSE American: CRMD) announced that Matt David, M.D., CFO, will present at the 2020 BIO Investor Forum Digital from October 13-15, 2020. The presentation will be available on demand. CorMedix focuses on developing therapeutic products for infectious and inflammatory diseases, notably the antibacterial solution Defencath, aimed at preventing bloodstream infections in chronic hemodialysis patients. Defencath’s NDA has been filed with a PDUFA date of February 28, 2021, and has received Fast Track designation from the FDA, granting added marketing exclusivity.

CorMedix announced FDA acceptance of its New Drug Application (NDA) for Defencath™, aiming to prevent catheter-related bloodstream infections in hemodialysis patients. The FDA has set a PDUFA date for February 28, 2021, with a priority review status granted. Defencath's clinical trial showed a 71% reduction in infections compared to standard care. CEO Khoso Baluch highlighted this as a pivotal step for the company and the patient community. CorMedix also noted the potential for additional indications and exclusive marketing rights subject to FDA approval.

CorMedix Inc. (NYSE American: CRMD) announced the pricing of its underwritten public offering, selling 4,444,444 shares at $4.50 per share, aiming for $20 million in gross proceeds. The offering is set to close on July 30, 2020, pending customary conditions. The proceeds will be utilized for general corporate purposes, including the regulatory approval and commercialization of Defencath™, research and development, and working capital. Underwriters have a 30-day option for an additional 666,666 shares.

CorMedix Inc. (NYSE American: CRMD) reported a Q1 2020 net loss of $5.6 million ($0.21/share), higher than the $5.2 million loss the previous year. Operating expenses rose 14% to $5.6 million, primarily due to increased SG&A expenses in preparation for a New Drug Application (NDA) for its lead product, Defencath™, which aims to prevent bloodstream infections in hemodialysis patients. The FDA conditionally accepted the proprietary name. The company has cash and short-term investments of $23.2 million, which, along with recent tax benefit sales, gives a pro forma cash total of $31.3 million, sustaining operations into Q2 2021.

CorMedix Inc. (CRMD) announced the appointment of Matt David, M.D. as Executive Vice President and Chief Financial Officer. Dr. David brings extensive experience in healthcare capital markets and strategy, essential for the company as it approaches regulatory approval for Neutrolin, its lead product aimed at preventing bloodstream infections in hemodialysis patients. Neutrolin has demonstrated a 71% reduction in related infections compared to traditional treatments, and it holds FDA Fast Track status. The company has commenced the NDA submission process for the product.