CorMedix Inc (CRMD) News

New contract announced yesterday. Wall Street reportedly
as of 8/15 is DOWN to 30% of the shares held by the
institutional players (down from 33% or so).
Tracking this number to see cause without WS
pushing the shares, buying the shares themselves, this
could be a rough ride to higher numbers.
For normally, an announcement like this would be at least
a 'minor' pop in the share price..

CRMD under $7

shares short # reportedly up to 19% of the outstanding

Institutional holdings have been running flat at roughly 32% for many months.

Has me wondering WHY wall street is seemingly not reacting to a company thats been approved
that has a product that is better for the end users than the current stand of care. Almost as if
they don't see it gaining market share or is it a case that some big pharma wants the product, cheap.
And therefore the share price is being kept tamped down by the short attacks and lack of institutional
buying that aids and abets the shorts efforts.

Stock price is show a lot weakness! I like to see it rally from here!

CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider
BERKELEY HEIGHTS, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin).
https://www.yourcentralvalley.com/business/press-releases/globenewswire/9144311/cormedix-inc-announces-commercial-agreement-with-top-tier-dialysis-provider/

thanks rmgillis for sharing....greatly appreciated

Heparin is purely for patency. It has no effect on Catheter related bloodstream infections (CRSBIs). Defencath (formerly Neutrolin) includes heparin as one of its main constituent. Taurodoline is the anti-infective component in Defencath- it uniquely prevents biofilm which allows infections to gain a foothold in the bloodstream.. . In Europe TauroPharm (German company) sells a virtually identical catheter lock they call TauroLock. It was originally licensed to them by the predecessor company of Cormedix, BioLink. Because the catheter lock solution is deemed a "device" and not a drug in Europe as it is in the USA (courtesy of the FDA) it didn't have to go through the arduous FDA approval process. Cormedix was unable to stop TauroLock from continuing to sell their product without permission or royalty in the German courts. There are a number of copycats in Europe where the market entry barriers are much lower.

Now that CRMD has the exclusive FDA approval for the only catheter lock solution approved in the US, they will enjoy many years without competition. Once they have enough revenue they will commence an Oncology trial which has many times the market potential of the diabetes catheter lock solution market -- which is essentially new diabetes patients starting dialysis while they wait for maturation of an AV graft that will result in a fistula for further dialysis access. There are also always ESRD (end stage renal disease) patients who are not fistula candidates who must remain on catheters for all of their dialysis sessions - these unfortunate patients will need Defencath to protect their indwelling catheters from infection and biofilm for their remaining lifetimes. Life expectancy and quality of life with Defencath should be much better for these patients.

Well so much for $6 (LOL)...

And yep, it dropped down to meet its MA line, no surprise there..

And FYI, today is option expiration day. Max Pain for CRMD today is around $4.. Hmmm

But nice spike into the open on I suspect the TDAPA PR..

Be interesting to see how long it takes IV to get back up this time. Wondering WHY someone went after that message board..

But I digress. 1st of all, given the tendency for lawsuits to be filed for anything and everything anymore. The question on SOC would
appear to be a moot one. You have an APPROVED compound that works better than the current UNAPPROVED product (heparin). And
unless the cost in comparison to heparin is too big a differential? One would expect the targets of those lawsuits including their insurance
carriers would be saying, use the FDA approved one, use the one that has a better outcome profile and lets do the most we can to avoid unnecessary
infections and possible deaths that could occur with a lesser product.

2nd, on the reimbursement rate?? I wouldn't worry about it at this stage, let the cards get played out. There are unknowns, that time will clear up..

I agree with you also, and my post was not intended to suggest that I don't think it will be SOC or profitable or that a major player won't use. Just seems like we can't win here. Every positive gets flipped on its head. We get a good piece of news and almost always the "yeah, but..." crowd wins. until all the unkowns are known, it will be used as ammo against us longs. If they do announce the reimbursement amount, (and please god, I hope I am wrong, but I don't think that will come until June) they need to at least say they are in deep discussions with providers or nearing agreements with providers or at lease getting positive feedback from providers. I know we have a winner here. But for the life of me, I can't figure out why the institutions don't feel the same. I kind of thought we would be around 60 or 65% ownership by now. And I have a really hard time thinking I am smarter than they are.

I agree with you. If they don't know yet they should have just said it's under negotiation or something. They just left everyone hanging. I do think it will be SOC with TDAPA though. No matter what the pricing is it will still increase revenue for any provider while at the same time reduce infection rates. They are judged by CMS on infection rates and rewarded or punished accordingly so they will all want it.

I don't comment much over there, but I watch and listen. You all are super smart and knowledgeable, and I am just a little guy. I saw the PR and quickly skimmed looking for the reimbursement amount. When I didn't see it, I read it, thinking I missed it. I don't think anything nefarious is going on, but that is a huge missing piece that leaves the door open for negative thoughts and provides an opportunity for others to push it down. We all think it should be SOC, but at this point, it is not. We know it will be reimbursed, but we do not know how much other than CMS is pretty cheap, so who really knows. We know Frensius and Davita are the 2 major players, but we have no confirmation they will buy. Everything looks good, and the puzzle is coming together, but without knowing how much they can make and who has agreed to buy, it just leaves too much room for skepticism. I have been here for 7 years, and I am usually very calm and patient, but I am really frustrated today. I'm so tired of waiting for the next catalyst only to be let down. Sorry for the negatively - it's not usually my thing and I am holding. GL

Anyone here from IV? Wondering your thoughts on no reimbursement rate mentioned for TDAPA news

Time for a 'pause'?? Be happy if it could hold over $6+ while its Moving Average line which got 'lost' catches up..

Gets too far apart and its interesting to see how the share price and MA line seem to want to get back together. And unfortunately, it usually involves the share price being dragged lower..

Disclaimer: finally getting the move we have been looking for. 1st target price: $14 (hemo sector), 2nd target price: $25 (IF they can get the oncology sector)

CRMD new 52 hi

Its all about MARKET CAP vs potential revenues.

Some of us who have been in this for a long time had a market cap of around $600 Million based on 'conservative' guesses for sales/pricing.
Gave me a target price of around $25-30 or so BEFORE the 1-5 r/split, with only 25 Mil or so shares outstanding post the 1-5. But now thanks to the dilution to raise cash, a share count of around 58 Million? Now my target price is down to around $14..

So while a 1-5 r/split has occurred, dilution that doubled the number of outstanding shares took place, the MARKET CAP that we 'guessed' at way back around 2016-2017 hasn't changed, won't change until the company/anal-ysts shed some more light on how things are going, and the anal-ysts update their revenue/profits and market cap 'expectations'..

So yeah, it has room to 'run' to the target price, thanks to the 2 frigging CRLS, the damage done has been to the target price expectations thanks to the dilution..
Good luck..

$CRMD 6 is still only 1.20 pre split
We got more room to run
Keep the positive news flowing Joe

Nice follow through on news breaking 5

https://stocktwits.com/newinvestor07/message/568773658

RMB. well little chance of hurricanes in the NW ..:--). Hope it works out for you .
As you know my wife is a Nephrology PA . She handles catheter infections roughly once every 2-3 months . The biggest demand for CRMD's product is likely to be in the roughly 25,000 cases I think of emergency dialysis in a hospital setting each year ...rather than in the routine dialysis clinic setting .

We are more interested in UNCY and ARDX for treating high serum phosphorus. Most of my wife's patients can not get to goal on the current meds ...pill burden and they hate the taste . ARDX has developed a pill taken twice a day but 50% experience diarrhea getting used to the drug. UNCY has developed a " condensed " version of an existing binder thats 1 pill a day with meals ..swallowed .
FDA has delayed approval requesting a tolerability trial with dialysis patients

https://ir.unicycive.com/news/detail/55/unicycive-therapeutics-reaches-alignment-with-the-fda-on

Respond to me on the UNCY board if you want more details

Kiwi

How big is the sales team and infrastructure supposedly trying to sell this in Europe compared to the organization they have in the U.S.?

Yep still here Kiwi. Have been totally distracted with this move to Pac NW.

If they can't sell it in the EU in any volume , what makes you think they will do any better in the US ?
Kiwi

By all means, the company faces a binary event now as it did in 2019 (when this article is from). However, I don't see how the article you refer to brings any information of value at the companys current situation.

https://nightmarketresearch.com/cormedix-infected-with-hype-valuation-swollen/

Kiwi

RMB. Are U still in this ? I'm probably starting a position tomorrow
Kiwi

Actually some one is watching ...my wife rounds dialysis clinics
PDUFA Nov 15
Kiwi

3.92 https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172236480&txt2find=crmd

$CRMD CorMedix Inc. Announces Pricing of $40 Million Public Offering of Common Stock and Pre-Funded Warrants
https://www.stocktitan.net/news/CRMD/cor-medix-inc-announces-pricing-of-40-million-public-offering-of-ouik9129vz5d.html

https://finance.yahoo.com/news/cormedix-inc-announces-proposed-public-200700586.html

See no one watching.... yet just slowly keeps rising.... my largest holding and enjoying the option money every month!!! And the rising price is NICE!!

well.... hasn't been great.... but as of late... money to be made buying on dips and then selling close in options... like at if next Friday still above I'll be making 12-15% on stock I bought .... some will only be about 2 weeks old.... these were extra shares bought believing it will be 5 next week.... wish I even bought more... do have some that I covered with June 6s and 7s that could work out good!! Bulk waiting for a good move up from here!!

Good luck!! Earnings on 15th

Could this has traded poorly since the announcement. Disappointed. Dilution could be the reason and market not happy about extended time frame.

I really don't like playing this "when will it be approved game" cause everyone gets too ramped up about made-up timelines. The company didn't really guide anything specific, and didn't leave room for error. For instance, API supplier #1 provided FDA responses and changes, but that doesn't mean FDA accepted. With that said, the absolute best case scenario I saw was (assuming everything goes well), is possible approval in September. Request meeting mid March, FDA responds early April (14 days), Meeting early May (30 days), prepare and resubmit NDA class 2 early to Mid July (2 months rough estimate not guided), FDA approves early to mid September (60 days). This is best case and assumes no new on site inspection of existing manufacturer. If inspection is required, move from Q3 to Q4. As far as new CMO, figure summer 2024. My best guess and I am no pro. Good luck.

News out AH today that the primary CMO has completed the corrective actions from the FDA
2022 inspection. Anyone now how soon now until approval or when the FDA will
reinspect the CMO facility and assuming it passes, how long until FDA approves?

Moving nice today!!! Up 7.41%!! Have another much hotter today ... but with the target here Happy to see it moving.... just Sold March 6s options. Love to see them take it from me at that price in 17 days!!! Have more not optioned!! They need $6.10 just to break even!!

Great day today.... well so far!!

Let's hope Joe can get this across the finish line.

Slowly creeping back up...... trying to. Just a little today .... hoping for lunch time pull back....

Price far below JMP target of 14 !!!

CRMD broke over 4 today!!! Nice move....

reslabrat...thanks for the info...and best of luck to all

Yeah, saw that. Good news for sure. Hoping we can finally get past that FDA hurdle and we are golden

NTAP Approval

This was posted today in the CMS FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule — CMS-1771-F Aug 01, 2022 Medicare Parts A & B.

"Applications for NTAP Approved for FY 2023"

"CMS also conditionally approved one technology under the alternative pathway for products that received FDA Qualified Infectious Disease Product (QIDP) designation that otherwise meets the alternative pathway criteria, but has not yet received FDA approval."

Maybe this is the NTAP approval for Defencath.

great news today...i bot more....burp

to me its a slam dunk...all in my opinion

just makes sense.

best to all

Company announced resubmission of defencath NDA this morning. No reason this should be under 10. Are their any short positions?

CorMedix to Participate in Upcoming January Conferences

BERKELEY HEIGHTS, N.J., Jan. 04, 2022 (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 CorMedix management will be participating in several upcoming investor conferences in January.

Investor Conference Details

LifeSci Partners – 11th Annual Corporate Access Event
Wednesday, January 5th – Friday, January 7th
To register and submit one-on-one meeting requests, Click Here

H.C. Wainwright Bioconnect Virtual Conference
Monday, January 10th – Thursday, January 13th
To register for the conference, Click Here

Biotech Showcase Virtual Conference
Monday, January 10th – Wednesday, January 12th
To register and submit one-on-one meeting requests, Click Here

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 DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with 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. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

At some point this will be FDA approved..the need for the product is off the map..the question remains..wtf is holding this up?

The stock was upgraded to 32 dollars just before the FDA approval was to be granted..Hoping for 12 dollars on a buyout is ridiculous.

Patience will pay off here.

As I said a few days ago..this is when you should be adding...not talking about selling the company for 12 a share..lol

Hopefully..we'll get an update with some positivity in it...there is an acute need for their products...this is taking so damn long to get FDA approval...

Grease the palms..let's get this done.

CorMedix Inc. to Report Third Quarter 2021 Financial Results and Provide a Corporate Update on November 9

BERKELEY HEIGHTS, N.J., Nov. 02, 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 report its financial results for the third quarter ended September 30, 2021, after the market close on Tuesday, November 9, 2021, and will host a corporate update conference call at 4:30pm Eastern Time.

Tuesday, November 9(th) @ 4:30pm ET
--------------------------------------
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13723602

I hope the CRMD BOD decides to place the company up for sale so the
production, marketing, and sales of this life-saving product can be
done by management that actually know what they are doing...I'd rather
take $12 today than have to wait years for a uncertain amount way out
in the future. Meanwhile, each day that goes by is one less day of
patent life protection.