Cormedix Stock Price, News & Analysis

CorMedix Inc. (Nasdaq: CRMD) announced that the U.S. FDA has accepted its resubmitted New Drug Application (NDA) for DefenCath, a catheter lock solution aimed at reducing catheter-related bloodstream infections in hemodialysis patients. This acceptance marks a significant milestone with a six-month review cycle. Both CorMedix and its contract manufacturer are preparing for an FDA onsite inspection. The FDA previously designated DefenCath as a Fast Track product, offering potential marketing exclusivity. Successful approval could enhance treatment options for patients with renal failure.

CorMedix Inc. (Nasdaq: CRMD) will report its financial results for the fourth quarter and full year ending December 31, 2021, post-market on March 29, 2022. The company focuses on developing therapeutic products for infectious and inflammatory diseases, notably its lead product DefenCath, designed to prevent bloodstream infections in hemodialysis patients. DefenCath has Fast Track and QIDP designations from the FDA, which offer extended marketing exclusivity. The NDA submission has faced issues but has been resubmitted addressing manufacturing deficiencies.

Joseph Todisco appointed as CEO of CorMedix effective May 16, 2022. With over 20 years in the specialty pharmaceuticals industry, Todisco aims to advance the company’s lead product, DefenCath, which has received FDA Fast Track and QIDP designations. He previously held senior roles at Amneal Pharmaceuticals, contributing to significant revenue growth. The company plans to pursue a commercial launch and expand its product pipeline. Interim CEO Dr. Matt David highlighted ongoing improvements following a Complete Response Letter from the FDA regarding manufacturing deficiencies.

CorMedix Inc. (Nasdaq: CRMD) has resubmitted its New Drug Application (NDA) for DefenCath to the FDA, addressing previously noted deficiencies in a Complete Response Letter. DefenCath is designed to reduce catheter-related bloodstream infections in patients undergoing chronic hemodialysis. The company's third-party manufacturer has also responded to necessary changes identified by the FDA. The FDA will review the resubmission for completeness within 30 days, and a preapproval inspection may be required.

CorMedix Inc. (Nasdaq: CRMD) announced participation in multiple upcoming investor conferences in January 2022. Key events include:

• LifeSci Partners – January 5-7
• H.C. Wainwright Bioconnect Virtual Conference – January 10-13
• Biotech Showcase Virtual Conference – January 10-12

CorMedix focuses on developing therapeutic products, notably DefenCath™, for preventing life-threatening infections related to central venous catheters in hemodialysis patients. The FDA has designated DefenCath as Fast Track and QIDP, offering extended marketing exclusivity upon NDA approval.

CorMedix Inc. (Nasdaq: CRMD) reported its third quarter 2021 financial results, announcing a net loss of $8.6 million or $0.22 per share, compared to a loss of $6.6 million in Q3 2020. The increase in losses was attributed to a 30% rise in operating expenses, primarily due to heightened manufacturing costs for DefenCath. Despite challenges, manufacturing activities have resumed, and the company aims to resubmit its NDA. With $72 million in cash, CorMedix believes it can fund operations through 2022. A conference call is scheduled for November 9, 2021 to further discuss developments.

CorMedix Inc. (CRMD) announced it will report its Q3 financial results on November 9, 2021, following the market close. The company specializes in developing therapeutic products for infectious and inflammatory diseases, with a focus on its lead product, DefenCath. This product aims to prevent bloodstream infections related to central venous catheters in chronic hemodialysis patients. DefenCath has received FDA Fast Track designation and QIDP status for marketing exclusivity. However, the company also noted it received a Complete Response Letter from the FDA due to deficiencies at its manufacturing facility.

CorMedix Inc. (Nasdaq: CRMD) announced the acceptance of three abstracts for presentation at major conferences, focusing on catheter-related bloodstream infections (CRBSIs) in hemodialysis patients. Key highlights include:

• 29% of ~56,000 hemodialysis patients experienced CRBSI after central venous catheter (CVC) insertion.
• 54% of first CRBSIs occurred within three months of CVC insertion.
• Annual costs of $2.3 billion from CVC-related infections were estimated.

Dr. Matt David emphasized the importance of these findings in addressing the high incidence of CRBSIs and the potential of DefenCath to reduce these infections by approximately 71%.

CorMedix Inc. (Nasdaq: CRMD) has announced significant changes in its executive leadership. Khoso Baluch has retired as CEO effective October 4, 2021, alongside John Armstrong, EVP for Technical Operations. Matt David, the current EVP and CFO, has been appointed as interim CEO while the Board initiates a search for a permanent replacement. Baluch will assist as an advisor during the transition. The changes aim to maintain momentum in advancing CorMedix’s key product, DefenCath, which is under FDA review for its potential to prevent infections in hemodialysis patients.