CorMedix Inc. develops and commercializes therapeutic products for life-threatening conditions, with a U.S. commercial focus in institutional settings of care. Its recurring news centers on DefenCath, a taurolidine and heparin product used to prevent catheter-related bloodstream infections in adult hemodialysis patients with central venous catheters, and on the specialty pharmaceutical portfolio added through the completed Melinta Therapeutics acquisition.
Company updates also cover anti-infective and hospital-focused products such as MINOCIN for Injection, REZZAYO, VABOMERE, ORBACTIV, BAXDELA and KIMYRSA, as well as TOPROL-XL. News themes include operating and financial results, commercial execution, clinical and regulatory disclosures for expanded product uses, shareholder voting matters, governance updates, investor conference activity and capital actions such as share repurchase authorization.
CorMedix Inc. (Nasdaq: CRMD) announced its meeting with the FDA to discuss the resolutions for deficiencies identified in the Complete Response Letter for the NDA of DefenCath™, a taurolidine/heparin catheter lock solution. A protocol for the manual extraction study has been agreed upon, and CorMedix aims to meet FDA requirements in the coming weeks. The timely resubmission of the NDA hinges on the completion of corrective actions prior to that submission. CorMedix is committed to resolving the noted deficiencies to facilitate the FDA's review process.
CorMedix Inc. (Nasdaq: CRMD) will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference, scheduled from April 12 – 15, 2021. The presentation will take place on April 14 at 4:30 pm Eastern Time. The company's lead product, DefenCath™, is designed to prevent bloodstream infections in hemodialysis patients. It has received FDA's Fast Track designation and Qualified Infectious Disease Product status, granting it extended marketing exclusivity. Visit cormedix.com for more information.
CorMedix Inc. (Nasdaq: CRMD) announced its financial results for Q4 and full-year 2020, reporting a net loss of $6.1 million in Q4 and $22.0 million for the year. Operating expenses rose 30% to $27.3 million, driven by increased R&D and SG&A expenses. The FDA rejected the NDA for DefenCath, citing issues at the manufacturing facility. Despite this setback, CorMedix plans to address FDA concerns and remains optimistic about DefenCath's potential. The company has $46.3 million in cash, expecting sufficient resources into H2 2022. A conference call is scheduled for March 30, 2021.
CorMedix Inc. (NASDAQ: CRMD) will report its fourth quarter and year-end financial results for 2020 on March 30, 2021, after market close. A corporate update conference call is scheduled for the same day at 4:30 PM ET. The company focuses on developing DefenCath™, an antibacterial and antifungal solution aimed at preventing bloodstream infections in chronic hemodialysis patients. DefenCath has received Fast Track designation from the FDA, which provides extended marketing exclusivity following NDA approval. Updates regarding manufacturing deficiencies are anticipated.
CorMedix Inc. (NASDAQ: CRMD) has received approval from the New Jersey Economic Development Authority to transfer $1.3 million in net operating loss (NOL) tax benefits to an unrelated profitable corporation. This initiative, part of the New Jersey Technology Business Tax Certificate Transfer program, is anticipated to yield $1.3 million in cash proceeds by Q2 2020. CEO Khoso Baluch highlighted that this funding supports the advancement of their lead product, DefenCath, towards a U.S. market launch, focusing on preventing bloodstream infections in chronic hemodialysis patients.
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.