CHM Cannabis
Home > Boards > US Listed > Medical - Healthcare >

CorMedix Inc (CRMD)

CRMD RSS Feed
Add CRMD Price Alert      Hide Sticky   Hide Intro
Moderator: dshade, orangecat
Search This Board: 
Last Post: 12/10/2018 9:17:46 AM - Followers: 97 - Board type: Free - Posts Today: 1

 

     

     
 

www.cormedix.com
 

 

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

Next

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.

Privacy   Terms of Use
© 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
FacebookTweetLinkedInGoogle +RedditDiggVKontakteStumbleuponEmailShareThis



 

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

CHM Cannabis
CRMD
Current Price
Volume:
Bid Ask Day's Range
  • 1D
  • 1M
  • 2M
  • 3M
  • 6M
  • 1Y
  • 2Y
  • 3Y
  • 5Y
CRMD News: Statement of Changes in Beneficial Ownership (4) 12/06/2018 04:21:48 PM
CRMD News: Amended Statement of Changes in Beneficial Ownership (4/a) 11/30/2018 04:25:24 PM
CRMD News: Amended Statement of Changes in Beneficial Ownership (4/a) 11/30/2018 04:23:44 PM
CRMD News: Amended Statement of Changes in Beneficial Ownership (4/a) 11/30/2018 04:23:07 PM
CRMD News: Amended Statement of Changes in Beneficial Ownership (4/a) 11/30/2018 04:22:57 PM
PlusOneCoin Top Posts
No plusone'd posts yet. Be the first!
PostSubject
#833  Sticky Note 7/25/18 News - Cormedix Inc. Announces Positive Results dshade 08/02/18 10:47:45 AM
#1607   No Buyout, but there‘s a partnership coming. Think axelvento 12/10/18 09:17:46 AM
#1606   ROAR. Rapture2020 12/07/18 11:12:32 PM
#1605   Sounds like a Christmas miracle! Rapture2020 12/07/18 11:10:21 PM
#1604   it was, then bounced proffetti 12/07/18 11:02:25 PM
#1603   Hardly, confetti. Rapture2020 12/07/18 05:36:18 PM
#1602   classic retracement, a test for some proffetti 12/07/18 02:36:07 PM
#1601   and hopefully the end of the vulgarity. proffetti 12/07/18 02:31:16 PM
#1600   a retest of 1.54 proffetti 12/07/18 02:27:36 PM
#1599   really? we're down over 8 cents now! proffetti 12/07/18 02:25:54 PM
#1598   hell yes, bitches, great close to janeyH 12/07/18 10:01:54 AM
#1597   Crossing my fingers for a big and interesting KC01905 12/07/18 08:03:58 AM
#1596   It's only the beginning!!!!!! axelvento 12/07/18 12:04:28 AM
#1595   LOL. BIG DAY. should continue to shareholder Rapture2020 12/06/18 10:02:44 PM
#1594   HOT DAMN!!!! janeyH 12/06/18 10:00:54 PM
#1593   HOT DAMN!!! janeyH 12/06/18 10:00:38 PM
#1592   * * $CRMD Video Chart 12-06-18 * * ClayTrader 12/06/18 05:32:18 PM
#1591   HOT DAMN!!! Rapture2020 12/06/18 05:12:54 PM
#1590   HOT DAMN!!! Rapture2020 12/06/18 05:12:51 PM
#1589   classic intraday bullish chart proffetti 12/06/18 01:27:03 PM
#1588   I like a stock that goes up in proffetti 12/06/18 01:15:16 PM
#1587   resumed run, nice dshade 12/06/18 12:55:04 PM
#1586   CorMedix initiated with a Buy at Roth Capital axelvento 12/06/18 07:57:57 AM
#1585   Im right there with u....scum. Staypositive1 12/05/18 04:11:34 PM
#1584   Shorts can shake my nuts. FDA news comes Rapture2020 12/05/18 03:39:55 PM
#1583   I'm think it will retest the dollar mark proffetti 12/05/18 03:18:33 PM
#1582   pumper LOL axelvento 12/05/18 04:10:36 AM
#1581   Yeah, clown statement. FDA at any moment. So Rapture2020 12/04/18 05:58:10 PM
#1580   d d DOW down over 700 pts proffetti 12/04/18 03:19:25 PM
#1579   you are right I bought 30 cent axelvento 12/04/18 09:12:50 AM
#1578   the whole world was green, so what . janeyH 12/04/18 08:59:42 AM
#1577   green day,,,, axelvento 12/03/18 08:41:36 AM
#1576   Even the investor who bought a million shares Vandalayind 12/01/18 08:38:28 AM
#1575   https://www.sec.gov/Archives/edgar/data/1410098/000165495418013406/xslF345X03/section16.xml axelvento 12/01/18 01:53:28 AM
#1574   wow what a comeback! axelvento 12/01/18 01:41:46 AM
#1573   Nice AH! Staypositive1 11/30/18 05:47:17 PM
#1572   What a high level board exchanging insightful and desarcmo 11/29/18 10:22:40 AM
#1570   Neutrolin® U.S. axelvento 11/29/18 04:18:23 AM
#1569   LOLOLOL. POST OF THE YEAR!!! Rapture2020 11/29/18 01:27:51 AM
#1566   = CRMD = Moved to BUY on Swing LiveLife 11/28/18 08:56:14 PM
#1562   than u agree with me. Kaplin holding 371 shooter45 11/28/18 06:06:11 PM
#1561   I think Khoso owns over 1.5M shares. You Rapture2020 11/28/18 05:59:57 PM
#1560   Sad part is those shares are imo a shooter45 11/28/18 05:56:43 PM
#1559   time will tell axelvento 11/28/18 09:31:43 AM
#1558   – Myron Kaplan, a Director at CRMD, purchased axelvento 11/28/18 09:09:12 AM
#1557   countdown F.D.A axelvento 11/28/18 08:47:00 AM
#1556   Over 100,000 shares. That’s a nice statement by Rapture2020 11/28/18 06:42:46 AM
#1555   i see insider buys$$$$$$$$$ axelvento 11/28/18 01:43:27 AM
#1554   Wow. What a day! So it begins... Rapture2020 11/27/18 08:46:37 PM
#1553   . Rapture2020 11/26/18 08:53:50 PM
#1552   Update on CORMEDIX website, re: Patent case. German Rapture2020 11/26/18 08:53:47 PM
PostSubject