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CorMedix Announces Proposed Public Offering of Common Stock
BERKELEY HEIGHTS, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD) (the "Company"), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that it plans to offer shares of its common stock in an underwritten public offering. In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the size or terms of the proposed offering.
The Company plans to use the net proceeds for general corporate purposes, including obtaining regulatory approval and commercialization of Defencath(TM) in the U.S., research and development, and working capital and capital expenditures.
After hours has not had a favorable response, probably because of dilution concerns.
Here is a new USA Today article that mentions INO. Could be an interesting tomorrow.
https://www.usatoday.com/story/news/health/2020/07/20/covid-19-vaccine-trials-attract-more-than-107-000-volunteers-so-far/5450983002/
This is a sloppy little myopic blurb that chooses to ignore multiple significant facts and makes gigantic flawed assumptions. Don't trust everything you read online and do your own research and make your own judgments. You will be much better off.
Moving along slowly. 60 days before NDA submission review complete. Then if given priority review another 6 months before approval. Nothing happening fast in the FDA review process.
BERKELEY HEIGHTS, N.J., July 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 all of the modules for the Defencath(TM) New Drug Application (NDA) have been submitted to the Food and Drug Administration (FDA). Defencath is being developed as a catheter lock solution with an initial indication for use of preventing catheter-related bloodstream infections (CRBSIs) in patients with end-stage renal disease who are receiving hemodialysis via a central venous catheter. The NDA was granted rolling submission and review by FDA as announced previously, and there has been ongoing dialogue with FDA as it reviews the submitted modules. The NDA contained data from the Company's Phase 3 trial, LOCK-IT-100, in patients undergoing hemodialysis for end-stage renal disease, which showed a 71% reduction in CRBSIs relative to the heparin control arm (p=0.0006) with a good safety profile.
The Company requested priority review of the NDA, based on the Fast Track and Qualified Infectious Disease Product Designations granted by FDA to Defencath. The FDA has 60 days to review the submission for completeness to make a filing decision and grant a priority or standard review. FDA will have a goal of a 6 month review period for priority review, compared to 10 months for a standard review.
https://content.seleritycorp.com/hosted2/assets/www/aFAIEVexU3HfOCIj6ORQ1WFxLSTBnqvkQ14RdHnFhJ0ath
It is about time someone is doing something about this. Been listening to these jokers for years being held unaccountable for the filth that they spread. Time for some to go down.
Same kind of results they have had in the past with RNA vaccines. Not sure why they expected different this time. But who cares? They got mega funding from the feds.
My little understanding of this issue is that RNA vaccines have had a problem during the take up of the vaccine into the cells. That is where INO's electroporation comes in. It apparently allows the incorporation of the DNA into the cells with better results. I have only enough knowledge in of all this to get me into trouble, I am a geologist, and I am sure there are smart people out there that can give a much better explanation. Now, we just need to see our results which should be released in the next few days.
Up over 5% premarket on 1.3. million shares. Setting up for a good start today.
Thanks. You are right, this is exactly the wrong time to play this stock. This is just the beginning and when it really moves it will go at lighting speed and you will never get the opportunity to reload with "cheap" shares. Riding this to the end when we are the next Big Pharma.
Waited a long time for this. Bought my first shares in 2013 for $2. Seen a lot of red along the way with lots of naysayers but now it is paying off. This coronavirus has sped the trials up and finally proving Dr. Kims DNA medicine. This virus thing is just the start, all the cancer trials are waiting in line. This is going to be a game changer that will change medicine. This is just the start. Lucky to be here for the ride.
Not a lot of volume. Going to take volume for big move, either way. Probably not much happening till the next news release, hopefully coming in the next week or two.
Nascarrat, is that a recent quote? Where from. Thanks
My guess is it may be good. Looks like high dose was effective and they want to see if the lower dose works. Saves a lot of vaccine and more people can be treated with smaller amount. Just my guess.
Take a look at the SEC filings for MRNA. Insiders have been selling like crazy over the last month cashing out. Doesn't look like the insiders have great confidence that this is going up, up , up.
https://www.nasdaq.com/market-activity/stocks/mrna/sec-filings
Never invest in what you don't understand.
Alive and well. Into second half of 2020 and waiting for the New Drug Approval (NDA) from the FDA, according to their February press release. Have not heard anything to the contrary and the pps has been rising so I consider that a good sign that all in on track. I really don't understand why there is not more interest in this stock. Granted they are low key and not a PR machine but looks like a solid company. Time will tell. Should be more action coming.
These things need to be explained to some of our less sophisticated posters. Use small words.
This was reported back in February. Maybe NDA approval is moving along. We have just begun the second half of 2020.
CORMEDIX INC. ANNOUNCES FDA GRANT OF ROLLING REVIEW OF NEUTROLIN® NEW DRUG APPLICATION
Berkeley Heights, NJ — February 3, 2020 — 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, announced today that the US Food and Drug Administration has granted the request for a rolling review of the New Drug Application (NDA) for Neutrolin® for the prevention of catheter-related blood stream infections (CRBSIs) in hemodialysis patients.
A rolling submission of the NDA is designed to expedite the review process for products being developed to address an unmet medical need. CorMedix remains on schedule for a potential NDA approval during the second half of 2020.
http://www.cormedix.com/cormedix-inc-announces-fda-grant-rolling-review-neutrolin-new-drug-application/
Don't really know what Warp Speed entails. Some of the 5 candidates haven't even started trials or testing. Proof will be in the pudding when INO Phase 1 trial results are made public. Nothing really big until Phase 2 finished and qualified for Phase 3. Long way to go and I think we are still farther ahead with new game changer DNA medicine. We also have the results for the 14 other DNA trials for additional diseases to look forward to.
Some interesting action this AM. Big buy down at the start but buying back up on some significant volume. What it all means, I don't know, but something going on.
Not sure that would qualify as a human trial.
Holding their breath
INOVIO to Host Webinar "DNA Medicines: From COVID-19 to Cancer"
- Leading Researchers and Scientists Detail INOVIO's Proprietary DNA Medicines Technology; Provide Updates on INO-4800 COVID-19 DNA Vaccine and INO-5401 GBM DNA Immunotherapy
- Webinar and Q&A 10 a.m. to Noon EDT on June 1;
https://investorshub.advfn.com/secure/post_new.aspx?board_id=13093
Moderna has an in with the Operation Warp Speed and their Czar. It will take gangbuster/gamechanger results on the phase 1 trials to have any chance to get in. Cards are stacked against INO right now. Companies with lesser vaccine progress have been promoted and given large sums of money right now.
Oxford University's candidate for coronavirus vaccine fails animal tests
Recent not very glowing article on the Oxford vaccine. Makes you wonder why the big US funding.
https://www.business-standard.com/article/international/oxford-university-s-candidate-for-coronavirus-vaccine-fails-animal-tests-120052000978_1.html
Oxford vaccine appears to be old style vaccine that treats with a weakened form of the original virus.
INO has a novel DNA approach to vaccine development and could prove to be a game changer.
Seeing more negative MRNA "analysis" lately. Guess now that they have a lot of free cash they are attracting the vultures. Another shiny object to attack. Too bad that crap is legal or ignored. Maybe this will change their focus off INO for awhile, at least until INO gets another big grant. I think stellar late June phase 1 trial results may shut them up for good.
Surprised US making huge investments in foreign company, even UK. Thought we were keeping this in-house. Did not learn from China, although UK is not China. Wonder if the INO China/S Korea connection is hurting federal funding? We got dribbles so far but to set up huge trials, like the 30,000 patient one for Asterazeneca it will take major dollars. Maybe we see something after Phase 1 trial results presented at end of month.
Trump Administration’s Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October
https://www.hhs.gov/about/news/2020/05/21/trump-administration-accelerates-astrazeneca-covid-19-vaccine-to-be-available-beginning-in-october.html
News talking heads say todays 3% overall market increase is due to optimism on the MRNA vaccine trial 1 results. Wait till they have favorable results on two vaccines! Excuse me, "vaccine candidates" as some people like to say. BTW, MRNA did not say "vaccine candidate". Lawyers will probably swarm them too.
Look at year to date charts. Since first of year INO has overall outperformed MRNA to date, percentage wise. NVAX followed INO graph until mid May where it has shot up way past both MRNA and INO. Haven't closely followed NVAX so don't know why the recent shoot up.
MRNA up 35% premarket on favorable trial results.
Warp Speed will be announced today. Hope it is fair and not full of cronies. Makes me suspect that the "therapeutics czar" is on the Moderna board. Dont trust politicians. If you are included lots of money coming your way.
By: Debbie Lord, Cox Media Group National Content Desk
Published: May 15, 2020 9:21 AM CDT
Photo Credit: Pedro Vilela/Getty Images
President Donald Trump will announce Friday a public-private partnership to speed the development of a vaccine against the COVID-19 virus.
Trump will lay out the details of “Operation Warp Speed” at noon in the Rose Garden.
The goal of the project is to bring together private pharmaceutical companies, government agencies and the military to try to cut the time it takes to develop a vaccine by as much as eight months.
“I think we’re going to have a vaccine by the end of the year, and I think distribution will take place almost simultaneously because we’ve geared up the military,” Trump said Thursday afternoon.
The program will be tasked with settling on up to four vaccines, testing them and then producing 100 million doses of vaccine that will be available by November, 200 million doses by December and 300 million doses by January, a senior administration official said.
Buys are trading at the ask. Good sign. Back to positive soon.
Yet. You live in the past. Look toward the future. Look at current numbers and tests. Completely different story. I put my money on the science.
Not just "robust" but "promising".
The Phase 1/2 clinical trial demonstrated that 84.4% percent (27 of 32) of patients with MGMT promoter unmethylated tumors, and 85% (17 of 20) of patients with MGMT promoter methylated tumors were alive at 12 months. This promising clinical result is coupled with a robust immunological response to all three cancer antigens in INO-5401.
Also "exciting". "May overcome more than 20 years of a standard of care".
Dr. David Reardon, Clinical Director, Center for Neuro-Oncology of Dana-Farber Cancer Institute (not a scam) and coordinating principal investigator of GBM-001 said, "Although these data are preliminary, and follow-up remains early, this novel combination of a cancer antigen-specific, T cell generating DNA medicine with a PD-1 inhibitor is exciting and may overcome more than 20 years of a standard of care that has proven sub-optimal for our patients with GBM.
Just trying to be through in posting and not leaving out significant facts.
Moncef M. Slaoui is on the board of Moderna and appointed government 'therapeutics czar'. Wonder why Moderna got the big federal grant? Sounds like a conflict of interest to me.
90,000, 100,000 and 300,000 buys in last few seconds.
INO HI folks, taking a moment to alert new readers that INO has a lot more going on than just the Coronavirus vaccine. INO also has cancer treatments for various cancers in Phase 3 and Phase 2 trials with results expected in later 2020. Look up all the facts on INO and its history. Sometimes posters leave out very critical information when it does not follow their theme.
Inovio Pharma files prospectus supplement for ATM offering of up to $100.0 mln of its common stock
4:43 PM ET 5/12/20 | Briefing.com
Good time to raise cash under favorable circumstances. More money will be available to fund cancer trials. We might be able to take phase 3 cancer trials to fruition with our own internal funding. Better for shareholders.
1.24% huge? Give me a break!
Lots of buys on the ask today with good volume. Maybe good news coming.