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Nice steady increase of late in a challenging market.
I sure hope it is moving higher for a "good" reason.
I wonder if HEPA will be acquired as that may be a good
scenario for a BP acquirer to acquire what could end being
one very valuable drug. I hope we steadily move to over $2.50
this year.
$CTRVW will pay big here in time. I’m bullish $HEPA
The place to make money with $HEPA is with the warrants. $CTRVW is Hepion Pharm Equity Warrant that Exp 3 Jul 2023. I expect I will see much, much larger gains there than the actual stock
Sorry, I was way off, current holdings:
Vanguard Group Inc ownership in HEPA / Hepion Pharmaceuticals Inc
2021-02-10 - Vanguard Group Inc has filed an SC 13G form with the Securities and Exchange Commission (SEC) disclosing ownership of 1,728,604 shares of Hepion Pharmaceuticals Inc (US:HEPA). This represents 5.96 percent ownership of the company.
HEPA Analyst Ratings
CONSENSUS
Strong Buy
Based on 2 analysts offering recommendations for hepa in the last 3 months.
Analyst Firms Making Recommendations
BROOKLINE CAP M
ROTH CAPITAL PA
Vanguard Group increasing to their position, they hold already quite a big position over 3.3M
Good signal!
That’s good. We need you around. I’ve been adding this past week and a half. We should be around bottom especially with 90mil in the bank.
Still holding and considering to add soon.
You’ve vanished just like our Hawaiian buddy. Did you get caught?
Still on vacation lol
$HEPA: CRV431 now known as RENCOFILSTAT
Hepion Pharmaceuticals Announces USAN Selection of Rencofilstat as Nonproprietary Name for CRV431
4:15 PM ET 1/6/22 | GlobeNewswire
Hepion Pharmaceuticals Announces USAN Selection of "Rencofilstat" as Nonproprietary Name for CRV431
EDISON, N.J., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and other liver diseases, today announced the United States Adopted Names ("USAN") Council has adopted the nonproprietary name "rencofilstat" for the Company's lead drug candidate, CRV431.
The USAN Council (tri-sponsored by the American Medical Association, the United States Pharmacopeia, and the American Pharmacists Association) works closely with the International Nonproprietary Name Programme of the World Health Organization and various national nomenclature groups to achieve global standardization and unification of drug nomenclature and related rules with the goal of ensuring that drug information is communicated accurately and unambiguously.
Going forward, Hepion will use the name "rencofilstat" in upcoming publications and public statements, at conferences and other forums, as the Company continues to advance the drug's clinical development.
About Hepion Pharmaceuticals
The Company's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies. In November 2021, the U.S. Food and Drug Administration ("FDA") granted Fast Track designation for rencofilstat for the treatment of NASH. That was soon followed in December 2021 by the FDA's acceptance of Hepion's investigational new drug (IND) application for rencofilstat for the treatment of hepatocellular carcinoma (HCC).
Hepion has created a proprietary AI platform, called AI-POWR(TM), which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR(TM) to help identify which NASH patients will best respond to encoflistat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR(TM) to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for encoflistat to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
> Dow Jones Newswires
January 06, 2022 16:15 ET (21:15 GMT)
This has to be one of the toughest holds ever. Hopefully 2022 is our year and the aholes zonking the price disappear. Glta
Over sold, i hope so
4 more days until tax loss selling ends
Maybe HEPA can get off its back then.
Someone Big is pounding this stock. A group with some heavy hitters. several 10K blocks
Here comes the Santa rally, break 1.39 and it can fast track to 1.5
Good to be loaded
Give it time. That's good for investors to buy. I'm ready to see my 1.75's green though ??
It's a damn shame. Wasting all these good pr's at this point. Any other stock would run to at least $10.plus on this press
Excellent!! Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer
Hepion Pharmaceuticals, Inc.
Tue, December 21, 2021, 5:00 AM·6 min read
In this article:
HEPA
0.00%
Explore the topics mentioned in this article
- New IND Expands Liver Disease Pipeline for CRV431 -
- IND Clearance Allows CRV431 to Move Directly into Phase 2 for Hepatocellular Carcinoma Treatment -
- New IND Provides for Complementary Therapeutic Approach of Treating NASH and Liver Cancer with a Single Once-a-Day Oral Agent -
EDISON, N.J., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and other liver diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its investigational new drug (“IND”) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (“HCC”).
On July 29, 2019, Hepion received FDA authorization of an IND to initiate the study of CRV431 for the treatment of NASH. To date, Hepion has completed Phase 1 studies in healthy volunteers and, more recently, announced positive data from its Phase 2a ‘AMBITION’ trial in subjects with presumed F2 and F3, where CRV431 was well tolerated, and all primary endpoints were met. A larger Phase 2b NASH study of over 300 subjects with paired liver biopsies, called ‘ASCEND-NASH’, is expected to be initiated in 2022. ASCEND-NASH will evaluate CRV431’s effects on the histologic endpoints of liver steatosis and fibrosis over 12 months dosing.
“Liver cancer is the sixth most prevalent cancer worldwide and is the second most common cause of cancer death,”1 commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “The most common form of liver cancer is HCC, which comprises about 90% of all liver cancers. Major risk factors associated with development of HCC include NASH, liver fibrosis and cirrhosis, viral hepatitis, chronic alcohol consumption, and metabolic syndrome. As the global prevalence of NASH is increasing, the incidence of HCC arising from NASH is also increasing. Approximately 25% to 30% of NASH-related HCC develops in the absence of cirrhosis and, therefore, occurs without many of the symptomatic warning signs of this aggressive form of cancer. An orally administered drug that simultaneously targets NASH and HCC would offer an advantageous therapeutic strategy to patients suffering these potentially life-threatening conditions. CRV431’s novel potential stems from its pleiotropic pharmacologic activities and from its ability to target the liver, allowing for a drug candidate ideally suited for the treatment of liver disease.”
Dr. Hobbs continued, “Another potentially important benefit is the patient experience while taking CRV431. Most cancer drugs are delivered by injection and are associated with significant side effects. In contrast, CRV431 is orally administered and has been shown to be well tolerated in clinical trials to date. We are optimistic that CRV431 may provide significant anti-cancer effects without imposing additional challenges and distress often associated with cancer drugs.”
Robert Foster, PharmD, PhD, Hepion’s CEO, said, “Increased cyclophilin isoform expression has been associated with negative outcomes in HCC. Importantly, CRV431 potently inhibits many of these isoforms in humans. Cyclophilins are enzymes that regulate many molecular and cellular activities that become dysregulated both in NASH and HCC. These dysregulated activities can lead to aberrations in signal transduction pathways, cell proliferation, cell death, extracellular environment including increased fibrosis, energy metabolism, inflammation, and immunity. Therapeutic intervention with CRV431 administration may reduce the pathologic potential associated with heightened cyclophilin activities in NASH and HCC, potentially allowing for a return to a healthier state.”
Dr. Foster continued, “CRV431 has shown anti-tumor activity in multiple animal studies, and our research team has been intensively investigating the specific mechanisms that have produced these outcomes. Our investigations have revealed interesting direct and indirect effects of CRV431 on cancer cells and tumors. For example, gene expression analyses have demonstrated CRV431’s ability to attenuate drug-resistance pathways and Wnt-ß-catenin-Myc signaling, the latter being mutationally over-activated in 30% to 50% of human HCC tumors. We recently also found that CRV431 increased lymphocyte infiltration into liver tumors in a manner similar to an immune checkpoint inhibitor, also known as an anti-PD-1 antibody, which is considered to be an important anti-tumor approach. We believe that the wide array of pharmacologic activities offered by CRV431 in the treatment of NASH and HCC should bode well for the further clinical development in both important indications.”
Reference
1Hepatocellular Carcinoma. Nature Reviews Disease Primers 7, 7 (2021).
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
Another sell the news event? Suppression at its finest. We should be valued higher than cash.
Same story every week. Pump then dump. Follow the trend. Buy up then short down. Ez$
I was right again
Gona break a new low again today. What a dump LOL
Still in Hawaii
Certainly nothing exciting but for a market day as red as it WAS $HEPA held up very nicely. The chart had the wind taken out of it a bit so nothing exciting there either. See how next week sets up for the Santa rally.
Big fail lol
$HEPA
Just so everyone knows that AKRO is starting a 2b Trial for NASH with Fast Track Designation, but has a greatly inferior drug, yet is trading at $20+ with PT in $60+.
So to be comparable, although CRV431 is a much more superior drug WITH MULTIPLE OTHER INDICATIONS, HEPA’s stock should be trading at $10+ with PT of $30+ just to be equally valued…when CRV431 is vastly more valuable!!!
Posted on ST
Excellent point Giovanni. Companies apply for fast track designation, along with breakthrough and orphan. If granted it can add exclusive marketing rights and give them a little more attention with the FDA.
But, none of it matters if the drug crashes and burns. That's why I mentioned just getting the fast track designation, while it's a good thing, it's not really a money maker. The science and company fundamentals are what counts. But, I'm thinking we'll have more confidence in HEPA's CRV431 as they move through their larger phase 2b trial.
Here's some more info on FDA designations
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
Always good to see you Giovanni. You always keep things real.
Message in reply to:
What percentage of fast track drugs get approved?
In contrast, fast track status has been conferred on 1,388 drug programs since the program was established by the 1997 FDA Modernization Act (FDAMA), according to BioMedTracker, and has resulted in 258 approvals – only about 20% of the designations. Negative outcomes also differ between the pathways.Apr 16, 2021
What percentage of fast track drugs get approved?
In contrast, fast track status has been conferred on 1,388 drug programs since the program was established by the 1997 FDA Modernization Act (FDAMA), according to BioMedTracker, and has resulted in 258 approvals – only about 20% of the designations. Negative outcomes also differ between the pathways.Apr 16, 2021
Robert Foster, PharmD, PhD, Hepion’s CEO, added, “This Fast Track designation provides for early and frequent communication with the FDA that will continue throughout the drug development and review process, which may lead to a more expedited drug approval and patient access to CRV431. Additionally, as part of the FDA Fast Track designation for CRV431 in NASH, Hepion will make its expanded access policy publicly available in the coming weeks.”
Just getting started.
I'm playing more off the technicals with a target of 1.80 short term.
HEPA daily chart showing an early sign of reversal. Of course the bottom needs to prove itself which if it holds 1.15 it just may do.
I like the science but I'm more on the technicals. If it pans out, what II keep as a core position will make out nicely.
I've seen much larger floats make CRAZY moves. Fast track is nice but it's not a money maker. But it's nice to have.
Anyway, this has been on my list for some time and only a quick swing once, so far. But like the looks much better now.
https://finviz.com/quote.ashx?t=hepa
Nothing against shorts, a team I trade with is big into shorting. Should be a link on my profile. (fixed it).
Thats when the OS was at 12 mil
$HEPA: ROTH Capitals Last update was PT of $14
That was before this announcement.
IT should be going higher and revised up again.
GO $HEPA
$HEPA: We shoud be getting an ANALYST upgrade...........
Before the week is over.
That'll take care of it for sure
$50 PRICE target MINIMUM !!!!!!!!!!!
GO $HEPA
Ok but theyre not. They are red. LOL
1.15 triple bottom. Trip and rips can be very volatile. Gets near the $ I'll be adding big time. There's a few others I'm watching but no one knows what'll happen tomorrow in this market. Thinking if the markets were as green as they are red today this would have easily crushed shorty.
LETS BREAK 1.15 lolol
What you got to say now? Back to 1.1’s LOLOLOL short it
Fast track means faster failure and faster short lololol
Thanks for reminding me to short
LOL WATCH IT DUMP HAHAHA
Like I said unfortunately we’re screwed till we’re not. Someone had their foot on our neck.
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Hepion Pharmaceuticals (Nasdaq: $HEPA) is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV).
Hepion announced top line data from the low dose cohort in the Company's Phase 2a ‘AMBITION' clinical trial of CRV431, an oral, once daily novel cyclophilin inhibitor. This Phase 2a study is continuing with the higher dose of 225 mg CRV431, with NASH patient dosing expected to be completed in Q1-2021.In 2021, of the more than 300 million people living with HBV infection, 10.5% (27 million) were aware of their infection. Non-alcoholic Fatty Liver Disease (NAFLD) affects up to 25% of people in the United States. There are currently no medicines that can cure non-alcoholic Fatty Liver Disease effectively. The same can be said with HBV. With the momentum growing around hepatitis B drug discovery research, we are closer than ever to a cure.
Fact: The inflows have been massive the last 2 weeks. Reason why In just 28 days at the low dose, HEPA CRV431 results were as good as what Madrigal's P3 lead NASH drug took 12 weeks to accomplish.
Bottom line The FDA looks for safety first we have the safest NASH drug our efficacy data is better than MDGL & AKRO. there market caps our almost 10x HEPA. Smart savvy biotech investors with deep pockets know this and are accumulating all they can of HEPA at these levels.
One morning we can wake up and see the price has tripled from its 160 market cap. Also they have 120 million in cash burning under 5 million a quarter. Lots of moving parts here. Gilead & Novo in the mix we will see? A new molecule being added to the pipeline. This management team is experienced 100 years total and world renown experts on cyclophilin inhibitors. They brought a FDA approved blockbuster drug to market already.
June 2021 Hepa Biz Presentation
https://hepionpharma.com/wp-content/uploads/2021/06/Corporate-deck-June-2021-FINAL.pdf
HEPA AI-POWR
https://hepionpharma.com/ai-powr/
HEPA Tackling Chronic Liver Disease - CRV431 Mechanism of Action
https://www.youtube.com/watch?v=CE7es4l1avM
HEPA GLOBAL NASH CONFERENCE PRESENTATION:
https://12ewye24eigk3g5kwa2dxjzm-wpengine.netdna-ssl.com/wp-content/uploads/2021/04/4thGlobal_NASH_Congress_Draft_20Apr2021_FINAL-1.pdf
HEPA website
https://hepionpharma.com
Chairman of the Board, Gary Jacob, is not just a business guy, he's one hell of a biochemist, and you can bet he has a solid grasp of everything that's going on with Hepion.
He's a key player here!
His background goes way beyond what you ordinarily see on the BOD of little R&D biotechs. You might see those with his research background on Scientific Advisory Boards, but they wouldn't have a fraction of the business expertise he's got.
Hepion has the whole package, with this guy!!
Hepion Pharmaceuticals Welcomes Dr. Stephen Harrison to its Scientific Advisory Board
https://www.globenewswire.com/news-release/2019/08/07/1898563/0/en/Hepion-Pharmaceuticals-Welcomes-Dr-Stephen-Harrison-to-its-Scientific-Advisory-Board.html
Former Novo Nordisk Executive, Dr. Todd M. Hobbs, Joins Hepion Pharmaceuticals as Chief Medical Officer
Todd Hobbs coming to Hepion. It was published in December. Hobbs' primary focus has always been on diabetes, and I have said many times that there's a blockbuster reason for him leaving his position as Vice President, Chief Medical Officer at Novo Nordisk, a USD 190B global pharmaceutical behemoth, after nearly 17 years there, to come to tiny Hepion.
I believe we'll be hearing about CRV431 in the treatment of diabetes, as it has the highest known potency of any reported cyclophilin inhibitor known, by a wide margin...
https://www.biospace.com/article/releases/former-novo-nordisk-executive-dr-todd-m-hobbs-joins-hepion-pharmaceuticals-as-chief-medical-officer/
Nash Phase 2 & 3 Trials by companies in the space:
AKRO Akero Therapeutics 1.1 Billion Marketcap 240 Million in cash
MDGL Madrigal Pharmaceutical 1.7 Billion Marketcap 300 Million in cash
HEPA Hepion Pharmaceuticals 160 Million market cap 120 million in cash
Currently trading at $2.2 due to a public offering of 44.000.000 shares $2
According to analysts' consensus price target of $80.00, Hepion Pharmaceuticals has a forecasted upside of 3,503.6% from its current price of $2.22.
$HEPA
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