CorMedix Inc. - 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.

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.