CorMedix

CorMedix, Inc. operates as a pharmaceutical and medical device company. The firm seeks to license, develop and commercialize prophylactic and therapeutic products for the prevention and treatment of infectious and inflammatory diseases. It is developing its product Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. The company was founded by Antony E. Pfaffle in 2006 and is headquartered in Berkeley Heights, NJ.

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CorMedix progresses on DefenCath NDA resubmission amidst financial challenges

CorMedix is actively working towards resubmitting the DefenCath NDA and preparing for commercialization, despite facing challenges in FDA interactions and financial performance. The company's strong cash position provides operational flexibility and readiness for potential NDA approval, with opportunities for growth in addressing CRBSIs.

CorMedix plans DefenCath launch in 2024, strengthens IP protection

CorMedix is strategically positioning for the potential commercial launch of DefenCath in early 2024, pending FDA approvals.
Despite financial challenges in Q1 2023, the company's strong IP protection and engagement strategies offer growth opportunities.

CorMedix reports key milestones and strong financial position in Q2 2023

CorMedix's Q2 2023 Earnings Call highlighted key achievements, financial updates, and strategic initiatives, showcasing the company's progress and readiness for upcoming milestones.
Despite facing challenges such as a net loss increase and operational complexities, CorMedix's strong financial position, milestones achieved, and strategic focus position it well for future growth and success.
With opportunities to drive commercialization, expand market access, and establish partnerships, CorMedix is poised to capitalize on its strengths and navigate challenges effectively in the evolving healthcare landscape.

CorMedix prepares for DefenCath launch with strong cash position

CorMedix is strategically positioned for the commercial launch of DefenCath, with a strong cash position and ongoing discussions with regulatory bodies for reimbursement. Despite challenges in operating expenses and net loss in Q3 2023, the company's focus on key catalysts in 2024 presents significant growth opportunities.

CorMedix reports Q4 loss, eyes profitability in 2024 amid milestones

CorMedix faces challenges with rising operating expenses impacting profitability but has achieved key milestones and optimized field operations.
Opportunities lie in label expansions, reimbursement approvals, and gradual market penetration strategies.
Maintaining financial discipline while pursuing growth initiatives will be crucial for CorMedix's success.
Overall, CorMedix's strategic focus on commercial launch and potential expansions sets the stage for future growth.

CorMedix progresses with DefenCath launch, eyes profitability by 2024

CorMedix is making strides with DefenCath's commercial launch and engaging key dialysis providers for procurement contracts.
Financially, the company aims for breakeven by end of 2024, supported by a credit facility and ample cash reserves.
Challenges include managing operating expenses and evaluating potential M&A opportunities for strategic growth.
Opportunities lie in outpatient commercialization, label expansion, and demonstrating DefenCath's value through real-world evidence studies.

CorMedix sees strong sales growth with DefenCath launch success

CorMedix's successful DefenCath launch generated $5.2 million in sales, with inpatient sales expected to rise in Q4. The company is focused on securing reimbursement from Medicare Advantage plans and funding clinical initiatives without significant dilution.

CorMedix reports strong Q3 results, eyes FDA approvals for growth

CorMedix's Q3 performance exceeded expectations, showing revenue growth and operational improvements.
While facing challenges in revenue guidance variability and increased expenses, the company is poised for EBITDA positivity in Q4.
Strengths lie in product acceptance, market expansion, and commitment to research, with opportunities in new agreements, studies, and FDA approvals.
Careful financial management and successful regulatory milestones will be key to capitalizing on growth opportunities and maintaining profitability.

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CorMedix, Inc. is a pharmaceutical and medical device company, which engages in the development and commercialization of therapeutic products for the prevention and treatment of diseases and conditions. The company was founded by Antony E. Pfaffle on July 28, 2006 and is headquartered in Berkeley Heights, NJ.

AnPac Bio-Medical Science Co

Surface Oncology Inc

AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Surface Oncology, Inc. (NASDAQ: SURF) and CorMedix Inc. (NASDAQ: CRMD) are among the biggest movers among health care stocks Tuesday.

Why AnPac Bio-Medical, Surface Oncology, CorMedix Are Rallying Today

BERKELEY HEIGHTS, N.J., March 08, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it will host a conference call relating to a regulatory update for DefenCath™ at 8:30am ET on March 9, 2021.

CorMedix Inc. to Host Regulatory Update Conference Call

CorMedix (CRMD) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: CorMedix (CRMD) Q4 Earnings Expected to Decline

The FDA gave a thumbs-down to CorMedix's antibacterial/anti-fungal catheter lock.

Why CorMedix Stock Is Crashing Today

The FDA has issued a Complete Response Letter for CorMedix Inc's (NASDAQ: CRMD) marketing application seeking approval for DefenCath (taurolidine/heparin catheter lock solution) for catheter-related bloodstream infections. FDA noted concerns at the third-party manufacturing facility after reviewing records, though the agency did not specify the issues.

FDA Strikes Out CorMedix's DefenCath Application

BERKELEY HEIGHTS, N.J., March 01, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility. FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. CorMedix expects to be able to complete this requirement expeditiously.

CorMedix Receives Complete Response Letter From FDA for DefenCath™ Catheter Lock Solution

BERKELEY HEIGHTS, N.J., Jan. 21, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has been approved for listing on the Nasdaq Global Market. The company's shares will continue to trade under its current symbol “CRMD”. Trading on the Nasdaq Global Market is expected to commence on Tuesday, February 2, 2021. The Company's shares of common stock will continue to trade on the NYSE American until the close of the market on Monday, February 1, 2021.

CorMedix Inc. to Begin Trading on the Nasdaq Stock Exchange

CorMedix (CRMD) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

CorMedix (CRMD) Upgraded to Buy: Here's Why

Does CorMedix (CRMD) have what it takes to be a top stock pick for momentum investors? Let's find out.

Here's Why Momentum Investors Will Love CorMedix (CRMD)

BERKELEY HEIGHTS, N.J., Nov. 18, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has decided to cancel the Antimicrobial Drug Advisory Committee meeting tentatively scheduled for January 14, 2021 to discuss the New Drug Application (NDA) for Defencath®. When the FDA accepted for filing the Company's submitted NDA and granted priority review, it set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021 for the completion of its review for approval of the NDA. The Agency noted that it was planning to hold an advisory committee meeting to discuss the application for Defencath to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI) and that it had not identified any potential review issues at that time. CorMedix has been notified that based on the Agency's ongoing dialogue with the Company, discussion at an advisory committee is not needed, and it will continue to work on the application with CorMedix during the remainder of the review cycle.

CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed

Candidate could get approval. But IP not very strong.

CorMedix: Patent Coverage Is A Problem

CorMedix Inc. (CRMD) CEO Khoso Baluch on Q3 2020 Results - Earnings Call Transcript

CorMedix's (CRMD) CEO Khoso Baluch On Q3 2020 Results - Quick Version Earnings Call Transcript

Seasoned industry veteran with decades of strategic and commercial leadership experience in the pharmaceutical sector Seasoned industry veteran with decades of strategic and commercial leadership experience in the pharmaceutical sector

CorMedix Appoints Greg Duncan to its Board of Directors

BERKELEY HEIGHTS, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it will report its financial results for the third quarter ended September 30, 2020, after the market close on Thursday, November 5, and will host a corporate update conference call at 4:30pm EST.

CorMedix Inc. to Report Third Quarter 2020 Financial Results and Provide a Corporate Update on November 5

BERKELEY HEIGHTS, N.J., Oct. 08, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that Matt David, M.D., Executive Vice President and Chief Financial Officer of CorMedix, will present a company overview and host one-on-one meetings during the 2020 BIO Investor Forum Digital, being held virtually October 13 – 15, 2020. The Company’s presentation will be available on demand for BIO Investor Forum attendees.

CorMedix to Participate in BIO Investor Forum Digital

It may be unusual to see nearly a 10% gain from a single analyst call. When analysts call for upside of more than 100% it can attract some attention.

Why CorMedix Could See 300% Upside From the Defencath Central Venous Catheter

Seasoned industry veteran with decades of strategic and commercial leadership experience in the pharmaceutical sector Seasoned industry veteran with decades of strategic and commercial leadership experience in the pharmaceutical sector

CorMedix Appoints Paulo Costa to its Board of Directors

BERKELEY HEIGHTS, N.J., Sept.  09, 2020  (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that CorMedix management will present a corporate overview at the virtual H.C. Wainwright 22nd Annual Global Investment Conference taking place on September 14 – 16, 2020.

CorMedix Inc. to Present at the H.C.

BERKELEY HEIGHTS, N.J., Aug.  31, 2020  (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s submitted New Drug Application (NDA) for Defencath™, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI). The FDA had previously granted a rolling submission and review, which the Company completed at the end of June.  The FDA also granted priority review and set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021 for the completion of its review for approval of the NDA.  The Agency noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time.

CorMedix Inc. Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Defencath

CorMedix (CRMD) saw a big move last session, as its shares jumped nearly 10% on the day, amid huge volumes.

CorMedix (CRMD) Jumps: Stock Rises 9.8%

CorMedix's (CRMD) CEO Khoso Baluch on Q2 2020 Results - Earnings Call Transcript

CorMedix (CRMD) delivered earnings and revenue surprises of 41.67% and -83.16%, respectively, for the quarter ended June 2020. Do the numbers hold clues to what lies ahead for the stock?

CorMedix (CRMD) Reports Q2 Loss, Misses Revenue Estimates

Conference Call Scheduled for Today at 4:30 p.m. Eastern Time Conference Call Scheduled for Today at 4:30 p.m. Eastern Time

CorMedix Inc. Reports Second Quarter and Six Month 2020 Financial Results and Provides Business Update

Cormedix (AMEX: CRMD) unveils its next round of earnings this Monday, August 10.

News for CorMedix Stock (CRMD)