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. (CRMD) announced its participation at the H.C. Wainwright Annual Global Investment Conference in New York from September 12-14, 2022. The company's presentation will take place on September 12 at 12:30 PM EDT. CorMedix focuses on developing therapeutic products to combat infectious and inflammatory diseases, including its lead product DefenCath, which aims to prevent bloodstream infections associated with central venous catheters in patients on hemodialysis. The FDA has designated DefenCath as Fast Track and QIDP, recognizing its potential to address unmet medical needs.
CorMedix Inc. (Nasdaq: CRMD) announced financial results for Q2 2022, reporting a net loss of $7.6 million, or $0.19 per share, up from $4.6 million in Q2 2021. Operating expenses increased approximately 41% to $8.3 million, driven by R&D and SG&A expenses related to its lead product, DefenCath. The FDA issued a second Complete Response Letter, requiring resolution of deficiencies at its manufacturing partners. Cash reserves stand at $64.6 million, sufficient to fund operations through at least Q3 2023. A conference call on August 11 will discuss these developments.
CorMedix Inc. (Nasdaq: CRMD) announced that the FDA issued a second Complete Response Letter (CRL) for its DefenCath New Drug Application (NDA), citing unresolved compliance issues at the contract manufacturing organization and heparin supplier. The company plans to resolve these deficiencies but expects delays beyond the PDUFA date. In addition, CorMedix has partnered with Alcami Corporation as an alternative manufacturing site for DefenCath and anticipates submitting a supplement to the NDA by Q1 2023. CMS has published conditions for New Technology Add-on Payment, which depends on FDA approval by July 1, 2023.
CorMedix Inc. (Nasdaq: CRMD) announced it will report its financial results for Q2 2022 on August 11, 2022, before market open. A conference call will follow at 8:30 AM ET. The company focuses on developing therapeutic products for infectious and inflammatory diseases, particularly its lead product, DefenCath™, aimed at preventing bloodstream infections in hemodialysis patients. DefenCath has received Fast Track and Qualified Infectious Disease Product designations from the FDA, which may enhance market exclusivity upon approval.
CorMedix Inc. (Nasdaq: CRMD) will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 15, 2022, at 10:30am EDT. The company focuses on developing therapeutic products for infectious and inflammatory diseases, particularly its lead product DefenCath, an antibacterial and antifungal solution for preventing bloodstream infections in hemodialysis patients. DefenCath has received FDA Fast Track and QIDP designations, offering significant marketing exclusivity upon NDA approval. More details are available on their website.
CorMedix Inc. (Nasdaq: CRMD) reported its Q1 2022 financial results with a net loss of $7.0 million ($0.18 per share), a slight improvement from a loss of $7.2 million ($0.20 per share) in Q1 2021. Operating expenses decreased by 3% to $7.0 million, driven by a 13% reduction in R&D costs. The company announced the FDA's acceptance of the DefenCath NDA resubmission and plans to focus on its U.S. commercialization while winding down European operations. As of March 31, 2022, cash and investments totaled $61.7 million, supporting operations through at least mid-2023.
CorMedix Inc. (Nasdaq: CRMD) announced key leadership changes aimed at enhancing its operational capabilities. Joe Todisco has been appointed CEO, with Liz Hurlburt promoted to EVP of Clinical & Medical Affairs. Donna Ucci and Frank Raffaele join as SVP of Global Quality and VP of Supply Chain, respectively. Tom Nusbickel departs the company. CorMedix plans to wind down European operations related to Neutrolin and focus on obtaining NDA approval for its lead product, DefenCath, which targets bloodstream infections in hemodialysis patients.
CorMedix Inc. (Nasdaq: CRMD) is set to report its Q1 financial results on May 12, 2022, after market close. The company, focused on developing therapeutic products for infectious diseases, is advancing its lead product, DefenCath™, designed to prevent bloodstream infections in hemodialysis patients. DefenCath has received FDA’s Fast Track and Qualified Infectious Disease Product designations. The company has addressed manufacturing deficiencies mentioned in a previous Complete Response Letter from the FDA regarding the New Drug Application (NDA) for DefenCath.
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.