Welcome to our dedicated page for Cormedix news (Ticker: CRMD), a resource for investors and traders seeking the latest updates and insights on Cormedix stock.
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) 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.
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.
