CorMedix Inc. - CRMD STOCK NEWS

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.

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.