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Cormedix Inc (CRMD) is a clinical-stage biopharmaceutical company pioneering novel therapies for life-threatening infectious and inflammatory conditions. This news hub provides investors and healthcare stakeholders with essential updates on DefenCath developments, regulatory milestones, and therapeutic pipeline progress.
Access timely announcements including FDA correspondence, clinical trial data, and commercialization strategies for CRMD's catheter lock solutions. Our curated collection features earnings reports, partnership disclosures, and scientific presentations relevant to infection prevention in critical care settings.
Key updates cover therapeutic candidate advancements, intellectual property developments, and market expansion initiatives. Monitor progress in addressing bloodstream infections through CRMD's specialized antimicrobial formulations designed for high-risk patient populations.
Bookmark this page for structured access to verified corporate communications and analysis of how CRMD navigates the complex biopharmaceutical regulatory landscape. Stay informed on developments impacting both patient care standards and long-term therapeutic innovation.
CorMedix Inc. (Nasdaq: CRMD) announced delays in its DefenCath New Drug Application (NDA) due to issues at its third-party manufacturer. These issues are unrelated to the manufacturing of DefenCath, and the timeline for addressing deficiencies is currently uncertain. DefenCath is designed to prevent bloodstream infections in hemodialysis patients and has received Fast Track designation from the FDA. The company has committed to conducting a pediatric clinical study upon NDA approval, which could extend marketing exclusivity.
CorMedix Inc. (Nasdaq: CRMD) reported a net loss of $4.6 million for Q2 2021, versus $3.8 million in Q2 2020, attributed to higher personnel costs and lower tax benefits. Despite a 34% reduction in operating expenses to $5.9 million, SG&A expenses rose 4% to $3.4 million. Cash reserves are robust at $78.3 million, expected to cover operations through 2022. The company aims to address FDA deficiencies and plans to re-submit its DefenCath™ NDA by Q4 2021. CorMedix emphasizes its commitment to delivering an antimicrobial solution for hemodialysis patients.
CorMedix Inc. (Nasdaq: CRMD) will announce its second-quarter financial results on August 12, 2021, following market close, and hold a conference call at 4:30 PM ET. The company is focused on its lead product, DefenCath™, which aims to prevent infections in patients with central venous catheters during hemodialysis. DefenCath has received Fast Track designation and was granted a Qualified Infectious Disease Product status by the FDA, allowing for additional marketing exclusivity upon NDA approval. Investors may gain insights into upcoming clinical studies and financial outlook during the call.
CorMedix Inc. (CRMD) announced the completion of a $1.3 million sale of tax benefits to a profitable New Jersey corporation through the New Jersey Technology Business Tax Certificate Transfer program for FY 2020. This program allows unprofitable technology firms to convert net operating losses into cash. The funding received will support CorMedix's growth, particularly for research and development. The company is also advancing its lead product, DefenCath™, aimed at preventing bloodstream infections in patients with central venous catheters.
CorMedix Inc. (Nasdaq: CRMD) will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 16, 2021, at 12:00 pm Eastern Time. This engagement highlights the company's efforts in developing therapeutic products for infectious diseases. CorMedix's lead product, DefenCath, aims to prevent bloodstream infections in hemodialysis patients and has received Fast Track designation from the FDA. The company also plans to conduct a clinical study for pediatric patients once the NDA is approved.
CorMedix Inc. (Nasdaq: CRMD) announced that its management will present a corporate overview at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 11:30 am ET. The company focuses on developing therapeutic products to prevent and treat infectious and inflammatory diseases, notably its lead product DefenCath, designed to prevent bloodstream infections linked to central venous catheters in hemodialysis patients. DefenCath is FDA Fast Track designated and awaits NDA approval after addressing manufacturing deficiencies.
CorMedix Inc. (Nasdaq: CRMD) reported its Q1 2021 financial results, showing a net loss of $7.2 million, or $0.20 per share, compared to $5.6 million, or $0.21 per share, in Q1 2020. Operating expenses rose by 29% to $7.2 million, primarily due to a 45% increase in SG&A expenses. The company raised approximately $41.5 million through equity financing and has cash reserves of $81.2 million as of March 31, 2021. CEO Khoso Baluch expressed confidence in advancing their antimicrobial solution, DefenCath, through regulatory approval despite ongoing FDA requirements.
CorMedix Inc. appoints Thomas Nusbickel as Chief Commercial Officer to lead the commercial strategy for DefenCath, an antimicrobial catheter lock solution aimed at reducing catheter-related bloodstream infections (CRBSI) in hemodialysis patients. Nusbickel's extensive experience includes leadership roles in renal product commercialization at Coherus Biosciences and Opko, as well as over two decades at Amgen. This strategic hire comes as CorMedix prepares for the FDA review of DefenCath, which has Fast Track designation and potential marketing exclusivity.
CorMedix announced it will report its Q1 2021 financial results on May 13, after the market close, followed by a conference call at 4:30 PM ET. The company is focused on developing its lead product, DefenCath, designed to prevent bloodstream infections in hemodialysis patients. DefenCath is recognized as a Fast Track product by the FDA, with additional marketing exclusivity provided by its QIDP designation. The company also aims to expand the use of DefenCath and leverage its taurolidine technology for other antimicrobial devices.
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical firm, announced participation in the 7th Annual Truist Securities Life Sciences Summit on May 4-5, 2021. The company focuses on developing products for infectious and inflammatory diseases, notably DefenCath™, an antibacterial solution aimed at preventing bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and QIDP designations from the FDA, providing potential marketing exclusivity. After a Complete Response Letter from the FDA regarding manufacturing deficiencies, CorMedix plans to further develop DefenCath for oncology patients and explore taurolidine technology in their pipeline.