Cormedix - CRMD STOCK NEWS

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.

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.