Cormedix Stock Price, News & Analysis

CorMedix (NASDAQ: CRMD) has signed a new three-year employment agreement with Liz Masson-Hurlburt, Executive VP and Head of Clinical Operations, running until March 2024. This appointment comes as the company pursues FDA approval for its product, DefenCath, aimed at preventing infections linked to hemodialysis. Masson-Hurlburt's leadership has been pivotal in successfully completing the LOCK-IT 100 clinical study. CorMedix is also expanding DefenCath's applications into oncology and total parenteral nutrition. The FDA has designated DefenCath as Fast Track and a Qualified Infectious Disease Product.

CorMedix Inc. (NASDAQ: CRMD) announced a conference call on March 9, 2021, at 8:30 am ET, to discuss a regulatory update for DefenCath™. This biopharmaceutical company is focused on developing therapies to prevent and treat infectious diseases, with DefenCath designed to prevent bloodstream infections related to central venous catheters in chronic hemodialysis patients. The FDA has granted DefenCath Fast Track designation and Qualified Infectious Disease Product status, extending its marketing exclusivity.

CorMedix Inc. (NASDAQ: CRMD) announced that the FDA cannot approve its New Drug Application for DefenCath™ in its current form due to unspecified concerns at a third-party manufacturing facility. The FDA requires a manual extraction study to validate the product's labeled volume. CorMedix aims to resolve these issues promptly and has plans to meet with the FDA by mid-April. Importantly, the FDA did not request additional clinical data, and approval is expected for a limited patient group. CorMedix ended Q4 2020 with approximately $87.8 million in cash to fund operations into mid-2022.

CorMedix Inc. (NYSE American: CRMD) has received approval to list on the Nasdaq Global Market, transitioning on February 2, 2021. This move aims to boost visibility among institutional investors and improve liquidity. CEO Khoso Baluch highlighted the significance of this change in light of the upcoming February 28, 2021 PDUFA date for the Defencath NDA review by the FDA. CorMedix focuses on developing Defencath, an antibacterial solution for preventing bloodstream infections in hemodialysis patients.

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.