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CorMedix Inc. develops and commercializes therapeutic products for life-threatening conditions, with a U.S. commercial focus in institutional settings of care. Its recurring news centers on DefenCath, a taurolidine and heparin product used to prevent catheter-related bloodstream infections in adult hemodialysis patients with central venous catheters, and on the specialty pharmaceutical portfolio added through the completed Melinta Therapeutics acquisition.
Company updates also cover anti-infective and hospital-focused products such as MINOCIN for Injection, REZZAYO, VABOMERE, ORBACTIV, BAXDELA and KIMYRSA, as well as TOPROL-XL. News themes include operating and financial results, commercial execution, clinical and regulatory disclosures for expanded product uses, shareholder voting matters, governance updates, investor conference activity and capital actions such as share repurchase authorization.
CorMedix Inc. (Nasdaq: CRMD) announced the formation of a new Scientific Advisory Board (SAB) on April 7, 2022. This board, composed of experts in nephrology, infectious diseases, medical nutrition, and pediatric oncology, aims to guide the development of DefenCath™, a catheter lock solution under FDA review for reducing catheter-related bloodstream infections in hemodialysis patients. The SAB will collaborate closely with CorMedix leadership as the company prepares for a potential commercial launch and seeks to expand DefenCath's applications.
CorMedix Inc. (Nasdaq: CRMD) announced a corporate overview presentation at the 21st Annual Needham Virtual Healthcare Conference scheduled for April 12, 2022, at 11:00am EDT. The company focuses on developing therapeutic products for infectious and inflammatory diseases, notably its lead product, DefenCath, aimed at preventing bloodstream infections in hemodialysis patients. DefenCath is recognized by the FDA with Fast Track and QIDP designations, enhancing its marketing exclusivity. A recent FDA Complete Response Letter regarding deficiencies has been addressed with a resubmitted NDA.
CorMedix Inc. (Nasdaq: CRMD) announced its financial results for Q4 and full year 2021, reporting a net loss of $7.8 million in Q4 and $28.2 million for the full year. Operating expenses rose by 8% year-over-year. A significant development includes the FDA's acceptance of the DefenCath NDA resubmission, which is under a six-month review. Cash and investments totaled $65.5 million as of December 31, 2021, projected to fund operations through mid-2023. CEO Joseph Todisco is set to lead the company starting May 16, 2022.
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.