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.
Summary not available.
Summary not available.
Summary not available.
CorMedix Inc. (Nasdaq: CRMD) announced plans to resubmit its New Drug Application (NDA) for DefenCath by mid-May 2023 after a productive Type A meeting with the FDA. The resubmission will leverage data from its existing contract manufacturing organization and a new heparin source. The FDA may conduct a pre-approval inspection during the review process. Additionally, CorMedix received a proposed New Technology Add-On Payment (NTAP) from CMS, potentially offering up to $17,111 per hospital stay for DefenCath, contingent on FDA approval by July 1, 2024. The anticipated new manufacturing process includes a 3 mL single-dose vial option. CEO Joe Todisco expressed optimism regarding NDA resubmission and the product's potential in hemodialysis infection prevention.
CorMedix Inc. (Nasdaq: CRMD) announced the appointment of Robert A. Stewart to its Board of Directors, expanding the board to 8 members, with 7 being independent. Stewart, CEO of Theramex, brings extensive experience from his roles at Amneal Pharmaceuticals and Allergan, which may help CorMedix transition from development to commercial operations. His expertise is expected to add value, particularly for the product DefenCath, designed to prevent infections in patients with central venous catheters.
Despite the positive leadership change, the company faces challenges, including a Complete Response Letter from the FDA regarding manufacturing deficiencies related to DefenCath. CorMedix is working to resolve these issues while also pursuing alternative suppliers and manufacturers, which may impact timelines.
CorMedix Inc. (Nasdaq: CRMD) reported its financial results for Q4 and FY 2022, showing a net loss of $8.2 million ($0.20/share) for Q4, compared to a $7.8 million loss in the same quarter of 2021. Full-year net loss increased to $29.7 million ($0.74/share) from $28.2 million in 2021, driven by higher operating expenses, particularly a 22% rise in SG&A costs. The company maintains $58.8 million in cash and short-term investments, sufficient to fund operations for at least 12 months. CorMedix has submitted a Type A meeting request to the FDA for its DefenCath application, with a meeting set for mid-April.
CorMedix Inc. (Nasdaq: CRMD) announced it will report its financial results for Q4 and year-end December 31, 2022, on March 30, 2023, before market opening. The company will also host a corporate update conference call at 8:30 AM ET. CorMedix focuses on developing therapeutic products, including its lead product DefenCath™, which aims to prevent bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and QIDP designations from the FDA, which could grant up to 10 years of marketing exclusivity upon approval. However, the company received Complete Response Letters (CRLs) due to deficiencies at its contract manufacturing organization, delaying NDA approval.
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.