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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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CRMD News: Current Report Filing (8-k) 11/27/2019 04:10:21 PM
PostSubject
#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
#2352   This thing couldn't have stayed down this week KC01905 11/20/19 10:45:38 AM
#2351   Ha. This is one of those times I Rapture2020 11/18/19 07:03:07 PM
#2350   Have not heard any news today to justify desarcmo 11/18/19 03:22:29 PM
#2349   Is Christmas coming early this year or is KC01905 11/18/19 01:14:54 PM
#2348   Moving up on decent volume. My guess is desarcmo 11/18/19 11:19:19 AM
#2347   No opinion. I usually take a month or Rapture2020 11/14/19 12:13:42 PM
#2346   Thanks, Rapture! I'll check them out, too. Do B52T38 11/14/19 12:11:32 PM
#2345   I sold all CRMD and placed it into Rapture2020 11/14/19 12:00:52 PM
#2344   Thanks, Janey, I'll check them out! I was B52T38 11/14/19 11:38:53 AM
#2343   Not pumping, just sharing, you will want to janeyH 11/14/19 07:25:29 AM
#2342   Hello, Rapture, I had a stake in CRMD B52T38 11/13/19 11:53:31 PM
#2341   I don’t think so. If FDA approval happens, Rapture2020 11/12/19 01:55:42 PM
#2340   This thing is the biggest tease ever. KC01905 11/12/19 01:47:11 PM
#2339   i still hold a tiny position here - janeyH 11/11/19 07:40:59 AM
#2338   BLAH Rapture2020 11/08/19 09:34:00 PM
#2337   * * $CRMD Video Chart 10-16-2019 * * ClayTrader 10/16/19 06:02:08 PM
#2336   CRMD bottom reversal http://www.stockta.com/cgi-bin/analysis.pl?symb=CRMD&cobra m1999 10/16/19 08:21:48 AM
#2335   CRMD~~NEWS~~CorMedix Completes Successful CMC Interaction with the FDA m1999 10/16/19 08:20:36 AM
#2334   looking good today, 5's the bottom proffetti 10/15/19 03:43:36 PM
#2333   It’s kinda sad but expected. In December 2017 Rapture2020 10/09/19 07:15:46 PM
#2332   dumpster city janeyH 10/09/19 05:36:14 PM
#2331   dang, rap, you called this one janeyH 10/09/19 05:35:13 PM
#2330   Hi. Rapture2020 10/09/19 04:56:46 PM
#2329   Hi, I am your new bagholder ... proffetti 10/09/19 03:29:01 PM
#2328   Is this a major buying opportunity or is KC01905 10/09/19 03:15:05 PM
#2327   I don’t see a near term catalyst so Rapture2020 10/01/19 06:01:42 PM
#2326   What happened today?!? My dog had a relapse KC01905 10/01/19 04:33:36 PM
#2325   Yeah i didn’t factor in Tute buying. It’s Rapture2020 09/27/19 02:21:44 PM
#2324   If you'd pardon my 2 cents ... proffetti 09/27/19 01:13:03 PM
#2323   250-300 range? you are really bearish janeyH 09/27/19 11:38:15 AM
#2322   Eject sequence initiated in early August. Now an Rapture2020 09/26/19 10:39:56 PM
#2321   wow people are just shitting all over this stock janeyH 09/26/19 05:52:19 PM
#2320   Any meaningful news from this bunch of yokels janeyH 09/26/19 02:53:31 PM
#2319   Not buying anymore until this bottoms out somewhere janeyH 09/26/19 02:52:59 PM
#2318   add add add 2manypips 09/18/19 03:28:50 PM
#2317   From their last 10Q about patent infringement by hmuney 09/08/19 09:19:32 PM
#2316   Agreed. I kept my initial position in the Rapture2020 08/27/19 04:16:36 AM
#2315   Wouldn't be a surprise if we saw it desarcmo 08/26/19 07:43:21 PM
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