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Neutrolin® granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product

Harnessing taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases

Neutrolin® a novel, non-antibiotic antimicrobial solution in Phase 3 development for the prevention of costly and dangerous bloodstream infections associated with the use of central venous catheters

Neutrolin® granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product

Harnessing taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases

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CorMedix Inc. is a commercial-stage pharmaceutical company focused on harnessing its taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases.

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© 2016 CorMedix Inc. All rights reserved.

400 Connell Drive, 5th Floor
Suite 5000
Berkeley Heights, NJ 07922




CorMedix Inc. is a pharmaceutical company that develops and seeks to commercialize therapeutic products for the treatment of cardiac and renal dysfunction, also known as Cardiorenal disease. Specifically, our goal is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications - in effect, "Treating the kidney to treat the heart.

Our therapeutic candidates for cardiorenal disease may be small molecules, biologicals, devices and/or diagnostics (tests) that enable therapy.
 

Cormedix Inc. Announces Positive Results Of Its Neutrolin(R) Phase 3 Lock-It-100 Study Based On Recommendation By Independent Data Safety Monitoring Board

News Provided by Accesswire2018-07-25
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MAJOR DEVELOPMENTS

Statistical Significance Achieved at Interim Analysis

BERKELEY HEIGHTS, NJ / ACCESSWIRE / July 25, 2018 / 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 independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. The company will submit the results of the interim analysis to the U.S. Food and Drug Administration for its review.

"We are thrilled to have received the DSMB's recommendation that efficacy has been demonstrated. Once we have submitted the interim analysis results and DSMB's recommendation to the FDA, we will begin the dialogue on the appropriate next steps," said Khoso Baluch, Chief Executive Officer of CorMedix. "We have invested a significant amount of the Company's resources over the last 2 ½ years in this study, and it is gratifying to have achieved this result based on the interim analysis. We believe Neutrolin has great potential to save lives of patients receiving hemodialysis therapy as a treatment for end-stage renal disease and to lower overall healthcare costs due to reducing the risk of catheter-related blood stream infections (CRBSI)."

The primary endpoint of the Phase 3 LOCK-IT-100 study is reducing the risk of occurrence of CRBSI by Neutrolin relative to the active control of heparin. The secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction, and catheter removal for any reason.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, in a Phase 3 clinical trial enrolling patients undergoing chronic hemodialysis that will be terminated early for efficacy. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the LOCK-IT-100 trial, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the resources needed to terminate the Phase 3 trial and the costs and time needed to submit a new drug application to the FDA; risks related to obtaining FDA approval of the new drug application for Neutrolin; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors
617-535-7746

SOURCE: CorMedix, Inc.

 

© 2018 Accesswire. All Rights Reserved.

Listen to what key opinion leaders have to say.
 
Click here  to listen to what a key opinion leader has to say about contrast induced acute kidney injury and the role catalytic iron and oxidative stress play in cardiovascular disease:
CormedixPeter McCullough, MD, MPH Consultant Cardiologist, Chief Academic and Scientific Officer with St. John Providence CormedixHealth System

Click here to listen to what a key opinion leader has to say about chronic kidney disease and catalytic iron:
CormedixSudir Shah, MD, Professor of Medicine, Director of Nephrology University of Arkansas College of Medicine, Little CormedixRock, AR

Click here to listen to a key opinion leader commenting on catheter related bloodstream infections, how they affect the dialysis patient population and current treatments available:
CormedixMichael Allon, MD, University of Alabama Birmingham, Birmingham Alabama

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PostSubject
#2402   Yeah, there are a lot. Hopefully they can SweatpantKing 11/25/20 09:48:54 AM
#2401   Only About a 260m market cap and the tone3 11/25/20 09:26:29 AM
#2400   After rereading their press releases they gave many tone3 11/25/20 09:15:10 AM
#2399   Smooth sailing! Hopefully they start talking oncology as SweatpantKing 11/24/20 11:21:41 PM
#2398   Nice steady climb with decent volume tone3 11/24/20 03:58:26 PM
#2397   If all goes as planned 15-20 bucks by February tone3 11/20/20 09:47:05 AM
#2396   Breaking News: $CRMD CorMedix Inc. Announces FDA Decision whytestocks 11/18/20 09:45:17 PM
#2395   solid update. just got the email alert dshade 11/18/20 08:43:33 AM
#2394   Next leg up should be next week proffetti 10/02/20 11:10:09 AM
#2393   Question ... is this going to be KC01905 09/22/20 07:19:47 AM
#2392   This should get some attention in a overall tone3 09/21/20 02:52:16 PM
#2391   Markets down -855 and were rocking baby! proffetti 09/21/20 02:37:51 PM
#2390   Forget the handle it's a parabolic move! proffetti 09/21/20 02:30:07 PM
#2389   Uh Oh! Cup and Handle Forming! proffetti 09/21/20 02:23:01 PM
#2388   We are on our way! up over 21% now proffetti 09/21/20 02:21:11 PM
#2387   I found the article, thanks. 50 if all tone3 09/21/20 02:12:41 PM
#2386   Truist Securities initiates at Buy proffetti 09/21/20 02:06:00 PM
#2385   Did I miss some new news tone3 09/21/20 01:46:19 PM
#2384   $CRMD $16.44 Million in sales last Qtr. proffetti 09/02/20 02:10:27 PM
#2383   First, no need to worry about defending management timberwolf7 08/26/20 11:34:26 PM
#2382   Not really surprised. Being a long time Lazerking40 07/28/20 08:18:43 AM
#2381   well, with around 25 Million shares available for timberwolf7 07/27/20 11:44:47 PM
#2380   CorMedix Announces Proposed Public Offering of Common Stock desarcmo 07/27/20 04:29:12 PM
#2379   News: $CRMD CorMedix Inc. Reports Submission of Defencath(TM) whytestocks 07/08/20 12:00:50 PM
#2378   Moving along slowly. 60 days before NDA submission desarcmo 07/08/20 10:22:54 AM
#2377   The lord giveth and the lord taketh away KC01905 06/11/20 05:40:04 PM
#2376   Alive and well. Into second half of 2020 desarcmo 06/05/20 06:18:54 PM
#2375   This thing is still alive?!? Hadn't checked since KC01905 06/05/20 12:58:15 PM
#2374   This was reported back in February. Maybe NDA desarcmo 06/03/20 05:43:09 PM
#2373   Maybe Something good coming our way tone3 06/03/20 03:42:08 PM
#2372   whats the brew haha up 52 pennies thumper1 06/03/20 03:37:53 PM
#2371   Updated April investor presentation. No big new news desarcmo 04/20/20 11:39:27 AM
#2370   Coming back from the hills. Good evaluation of CRMD! tone3 03/17/20 10:22:37 AM
#2369   People are running for the doors because of desarcmo 03/17/20 09:56:11 AM
#2368   Dilute at will, while there's still sucker buyers proffetti 03/13/20 05:12:37 PM
#2367   Yes but look what happened to Job after rawsteel 03/05/20 11:38:44 AM
#2366   The lord giveth and the lord taketh away KC01905 03/05/20 10:41:16 AM
#2365   CorMedix Gets FDA Rolling Review of NDA for rawsteel 02/03/20 09:09:45 AM
#2364   Updated January 2020 investors presentation on CRMD website. desarcmo 01/02/20 09:23:09 AM
#2363   This thing will forever keep you on the KC01905 12/20/19 11:28:46 AM
#2362   Quick correction to B. Riley price target: saturn_five 12/19/19 06:46:18 PM
#2361   i'll take 8 by days end lol. in thumper1 12/19/19 02:18:06 PM
#2360   How about just 8 by days end lol. KC01905 12/19/19 02:03:11 PM
#2359   looking strong again, i will take rileys rec, thumper1 12/19/19 11:52:22 AM
#2358   * * $CRMD Video Chart 12-18-2019 * * ClayTrader 12/18/19 04:36:21 PM
#2357   B.Riley really likes CRMD...best to all longs thumper1 12/18/19 09:36:46 AM
#2356   CorMedix (NYSEMKT:CRMD) initiated with Buy rating and $15 desarcmo 12/18/19 09:19:03 AM
#2355   Time to load it!! Hit low 5 's tmeier 12/13/19 12:57:13 PM
#2354   Chilling. Waiting on FDA’s AGRX decision. Haven’t forgotten Rapture2020 12/10/19 07:52:16 PM
#2353   hey , been quiet, what up? janeyH 12/10/19 07:50:59 PM
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