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. (Nasdaq: CRMD), also referred to as CorMedix Therapeutics in recent announcements, generates frequent news as a biopharmaceutical company focused on therapeutic products for life-threatening conditions and diseases. Its updates cover commercial performance, clinical development, corporate transactions, and capital markets activity, giving investors and healthcare professionals multiple angles from which to follow the company.
News about CorMedix often highlights the commercial rollout and utilization of DefenCath, an antimicrobial catheter lock solution approved to reduce catheter-related bloodstream infections in certain adult hemodialysis patients using central venous catheters. Press releases have discussed real-world evidence studies with outpatient dialysis organizations, including reductions in infection rates and hospitalizations, as well as recognition such as an Innovative Technology designation from Vizient.
Following its acquisition of Melinta Therapeutics LLC, CorMedix news also covers a broader anti-infective portfolio, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV, BAXDELA, and KIMYRSA, along with TOPROL-XL. Investors can expect updates on sales trends, integration progress, and synergy capture related to this transaction. Clinical news includes milestones in the Phase III ReSPECT study of REZZAYO for prophylaxis of invasive fungal disease in allogeneic blood and marrow transplant patients, as well as studies of DefenCath in Total Parenteral Nutrition and pediatric hemodialysis populations.
Regulatory and financial announcements are another important category, such as quarterly and annual results, revenue guidance changes, equity and debt financings, and SEC filings describing material events. Strategic items, including CorMedix’s investment in Talphera and associated board representation and negotiation rights, also appear in the company’s news flow. For investors tracking CRMD, this news page provides a centralized view of earnings releases, clinical data readouts, product designations, conference presentations, and governance updates.
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.
CorMedix Inc. (Nasdaq: CRMD) announced it will report its financial results for Q2 2022 on August 11, 2022, before market open. A conference call will follow at 8:30 AM ET. The company focuses on developing therapeutic products for infectious and inflammatory diseases, particularly its lead product, DefenCath™, aimed at preventing bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and Qualified Infectious Disease Product designations from the FDA, which may enhance market exclusivity upon approval.
CorMedix Inc. (Nasdaq: CRMD) will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 15, 2022, at 10:30am EDT. The company focuses on developing therapeutic products for infectious and inflammatory diseases, particularly its lead product DefenCath, an antibacterial and antifungal solution for preventing bloodstream infections in hemodialysis patients. DefenCath has received FDA Fast Track and QIDP designations, offering significant marketing exclusivity upon NDA approval. More details are available on their website.
CorMedix Inc. (Nasdaq: CRMD) reported its Q1 2022 financial results with a net loss of $7.0 million ($0.18 per share), a slight improvement from a loss of $7.2 million ($0.20 per share) in Q1 2021. Operating expenses decreased by 3% to $7.0 million, driven by a 13% reduction in R&D costs. The company announced the FDA's acceptance of the DefenCath NDA resubmission and plans to focus on its U.S. commercialization while winding down European operations. As of March 31, 2022, cash and investments totaled $61.7 million, supporting operations through at least mid-2023.