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) announced significant updates regarding FDA compliance remediation at its primary contract manufacturing organization and heparin API supplier. The company confirmed that all corrective actions from the June 2022 FDA inspection have been completed by its primary CMO. There’s uncertainty regarding the complete resolution of a warning letter affecting the heparin supplier, but recent FDA approvals suggest it might not hinder the NDA for DefenCath. CorMedix plans to request a Type A meeting with the FDA to clarify submission pathways and aims to resubmit its NDA as soon as possible, potentially classifying it for a 60-day review. Additional updates are expected in March.
CorMedix Inc. (Nasdaq: CRMD) has announced significant organizational changes aimed at enhancing its commercial strategy. Erin Mistry has been promoted to Executive Vice President and Chief Commercial Officer, overseeing the launch strategy for DefenCath, the company’s lead product designed to prevent infections in hemodialysis patients. Dr. Tushar Mukherjee is now Senior Vice President, Head of Technical Operations, responsible for final validation processes. These promotions are seen as key steps towards transitioning CorMedix from development to commercialization, reinforcing the leadership team as they move closer to launching DefenCath, which has FDA Fast Track and QIDP designations.
CorMedix Inc. (Nasdaq: CRMD) announced a poster presentation at the ASHP conference highlighting a study of kidney failure patients on hemodialysis with central venous catheters. Of 51,161 patients studied, 33% developed catheter-related bloodstream infections (CRBSIs), significantly increasing mortality rates and long-term complications. Patients with CRBSIs had a 30-day mortality rate of 10.8% compared to 2.0% for others. CorMedix aims to address this challenge with its product, DefenCath, which has shown the potential to reduce CRBSIs by approximately 71% in clinical studies.
CorMedix Inc. (Nasdaq: CRMD) reported its third-quarter 2022 financial results, posting a net loss of $6.9 million, or $0.17 per share, an improvement from a $8.6 million loss in Q3 2021. Operating expenses dropped 19% to $7.0 million, despite a 21% rise in SG&A costs driven by pre-launch activities for DefenCath. The company announced increased reimbursement for DefenCath and outlined plans to resubmit its NDA by Q1 2023. As of September 30, 2022, cash and short-term investments stood at $59.0 million, sufficient to fund operations through at least 2023.
CorMedix Inc. (Nasdaq: CRMD) announced a significant increase in reimbursement for its product DefenCath by CMS, raising the maximum reimbursement from $4,387.50 to $14,259.38 per hospital visit. This change reflects a correction in the estimated average usage of DefenCath during hospitalization. The NTAP reimbursement is contingent upon FDA's final approval of DefenCath by July 1, 2023. CEO Joe Todisco emphasized the importance of financial incentives for hospitals to address catheter-related bloodstream infections (CRBSIs) in hemodialysis patients.
CorMedix Inc. (Nasdaq: CRMD) will announce its financial results for Q3 2022 on November 10, 2022, before market open. A corporate update conference call is scheduled for 8:30 AM ET. The company is focused on its lead product, DefenCath™, designed to prevent bloodstream infections in patients undergoing hemodialysis. DefenCath has received FDA Fast Track and QIDP designations, but the company is facing delays due to unresolved deficiencies at its contract manufacturing organization. CorMedix is also developing other products and solutions, including taurolidine-based therapies.
CorMedix Inc. (Nasdaq: CRMD) announced that an abstract highlighting a retrospective analysis on catheter-related bloodstream infections (CRBSIs) in hemodialysis patients has been accepted for presentation at the American Society of Nephrology meeting on November 3-6, 2022. The study revealed that approximately 33% of the 51,783 patients studied experienced CRBSIs post-central venous catheter (CVC) insertion, with 47% occurring within three months. CEO Joseph Todisco emphasized the need for improved interventions, noting that their product, DefenCath, could reduce such infections by around 71%. CRMD continues to work toward FDA approval.
CorMedix Inc. (CRMD) announced its participation at the H.C. Wainwright Annual Global Investment Conference in New York from September 12-14, 2022. The company's presentation will take place on September 12 at 12:30 PM EDT. CorMedix focuses on developing therapeutic products to combat infectious and inflammatory diseases, including its lead product DefenCath, which aims to prevent bloodstream infections associated with central venous catheters in patients on hemodialysis. The FDA has designated DefenCath as Fast Track and QIDP, recognizing its potential to address unmet medical needs.
CorMedix Inc. (Nasdaq: CRMD) announced financial results for Q2 2022, reporting a net loss of $7.6 million, or $0.19 per share, up from $4.6 million in Q2 2021. Operating expenses increased approximately 41% to $8.3 million, driven by R&D and SG&A expenses related to its lead product, DefenCath. The FDA issued a second Complete Response Letter, requiring resolution of deficiencies at its manufacturing partners. Cash reserves stand at $64.6 million, sufficient to fund operations through at least Q3 2023. A conference call on August 11 will discuss these developments.
CorMedix Inc. (Nasdaq: CRMD) announced that the FDA issued a second Complete Response Letter (CRL) for its DefenCath New Drug Application (NDA), citing unresolved compliance issues at the contract manufacturing organization and heparin supplier. The company plans to resolve these deficiencies but expects delays beyond the PDUFA date. In addition, CorMedix has partnered with Alcami Corporation as an alternative manufacturing site for DefenCath and anticipates submitting a supplement to the NDA by Q1 2023. CMS has published conditions for New Technology Add-on Payment, which depends on FDA approval by July 1, 2023.
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