Cormedix - CRMD STOCK NEWS

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.