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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.
$HEPA: Sure you did...... We all BELIEVE YOU.
Sureeeeeeeeeeeeeeeeeeeeeeeee sure sureeeeeeeeeeeeeee
Now you can leave from here forever now that you're done ????
GO $HEPA
I already got what i wanted and covered. But watch it dump its gains in a few days
That’s the problem. These crooks are tough. Lets see if we hold some gains or end red like previous PR’S
Target 1.60's - 1'80's (doesn't have to be today but the chart looks close to reversal). Like the looks of this one too to keep a core.
$HEPA: NASH treatment space is such a difficult SPACE
Even major pharmas are having a difficult time making headways in it.
For the FDA to finally recognize that HEPA has been making positive developents and strides in that
direction means that those Majors are FINALLY gonna give HEPA a serious look.
I guarantee you that HEPA will be a takeover target in the very near future.
Todays prices are a Bargain Basement Steal under $2
People who understand this will benefit greatly
FORTUNE FAVORS the BRAVE..... and ASTUTE
GO $HEPA
$HEPA FDA consider crv431 a drug with excellent efficacy and safety profile to potentially treat Nash. A very good support from FDA to Hepion.
$HEPA (+13.9% pre) Could easy go 50-100% today!!!
Lets toast the criminals and move this up 50-100% today, and force them to cover. Short squeeze!!!
Fast Track! Yesssss!!! This just made us F'n rich
$HEPA , Fast track is GOOD news..
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
$HEPA: FINAALLLYYYYYYYYYYYYYY............. its about DAMN TIME !!!!!!!!!!!!
This one has just taken forever
Easily a $50/stock
SAVA style
Stupid stupid cheap here at 1.35
GO $HEPA
$HEPA news....
Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH Hepion Pharmaceuticals, Inc.
EDISON, N.J., Nov. 30, 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 granted Fast Track designation for the Company’s lead drug candidate, CRV431, for the treatment of NASH.
The FDA Fast Track designation allows sponsors to gain access to expedited drug approval reviews for medical conditions that are serious and potentially life-threatening, and where there is an unmet medical need. The program is also designed to facilitate drug development by making provisions for more frequent meetings with the FDA to discuss drug development plans, and Fast Track designation can lead to Accelerated Approval and/or Priority Review eligibility if certain criteria are met.
“CRV431 has been investigated in healthy subjects during our Phase 1 program, and more recently in subjects with presumed F2 and F3 NASH in our Phase 2a AMBITION study,” commented Todd Hobbs, MD, Hepion’s Chief Medical Officer. “Administered once daily as an oral soft gel capsule, CRV431 has been well-tolerated and has shown signals of efficacy in NASH in this early Phase 2 study. We are now looking forward to initiating our larger Phase 2b NASH study, called ‘ASCEND-NASH’, in biopsy confirmed F2 and F3 NASH subjects in the coming months.”
Dr. Hobbs continued, “We are keenly aware that there remains an urgent global need to develop NASH-specific therapeutic drugs for this potentially life-threatening condition, for which there are currently no FDA approved drugs. Furthermore, the American Liver Foundation estimates that at least 5% of the U.S. adult population has NASH. As such, we are very pleased to receive the FDA’s Fast Track designation and are looking forward to working closely with the Agency as we advance development of CRV431.”
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.”
$HEPA load the boat we are ready to lift off!!!
Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH Hepion Pharmaceuticals, Inc.
https://www.stonkmoon.com/news/HEPA/48b86544f281dfa4cad0def45bc9fcfa
Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH Hepion Pharmaceuticals, Inc.
LOL ok you hold
Just hold and add. I think it will do a big run in 2022…
This is turning into a major dumpster fire. I’m being to feel we are all screwed here.
Added yesterday @1.37, today tried to ad @1.28 not getting any. Avg @1.79
$HEPA Mcap 99M, cash on hand 90M
$1.18 will be absolute bottom, pps will not go under it this time around
Added @ $1.31 my. Avg is now $1.90 :)
Waiting for the big dump to sub 1
1.29 ugh lmaoooo hahahahahhaha!
1.33 hell yea how low can we go!
1.3s will be the new norm til it goes to 1.2s and then 1.1s
I didnt fail anything. This is in the 1.4s, lowest its ever been and might go lower tomorrow. Im not gona load a shady stock like this, im gona short it.
$HEPA: You failed to get the jist of the message
Never mind.
All the EV companies aren't TESLA either.......... yet they are all on fire.
Anyways, I'm loading here.
To the Victor go the SPOILS.
Not my First rodeo here.
Already killing it on ELEK today as well.
I know a thing or two about getting yield
GO $HEPA
This isnt sava lol
$HEPA: Right now is where you load............
When you think things are super miserable.
OVerfocus on the what coulda beens rather than about whats about to come will hinder your abiiity to
get a nice yield to the upside.
Its usually the dog stocks that have one of those SUPER NOVA days that make you look back if you're not
in them before that............ what was I thinking.
All CRV431 needs with more of these kinda positive developments is for a big pharma to endorse their
work if not come up with something even bigger in the near future.
Like $SAVA ran to over $130, this one has that TOTAL potential on the table
GO $HEPA
Agree with your thoughts, but right now we are screwed till we are not.
$HEPA: So they didn't get their share raise..........
And are still developing CRV431 with positive outcomes as observed in this latest study.
So tell me, how is that a bad thing ????
Where's the Motivation or Intent in that ?
Would you rather that they have NEGATIVE results issued on the study instead ?
Is that what would be good for the company in compariosn to other NASH stocks out there ?
Tell me another NASH stock thats got more potential with greater upside yield than $HEPA right now ???
GO $HEPA
They are angry they didn’t get there share raise and are suppressing the price.
$HEPA: What do you mean "Crime Sydnicate"
Are they the ones that are "FABRICATING" results on positive observations on CRV431.
What else do you want them to do??
GOT some ideas ???
GO $HEPA
Yes. But the bad news is the crime syndicate is still in control here. They are trying their hardest to get retail to sell.
$HEPA: Good NEWS on CRV431 in a Nonclinical Liver-Cancer-Study
Hepion Pharmaceuticals and FibroFind Announce Anti-Cancer Activity of CRV431 in a Nonclinical Liver Cancer Study
8:45 AM ET 11/16/21 | GlobeNewswire
Hepion Pharmaceuticals and FibroFind Announce Anti-Cancer Activity of CRV431 in a Nonclinical Liver Cancer Study
EDISON, N.J., Nov. 16, 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 the results of a nonclinical research study showing that CRV431 significantly decreased the growth of liver tumors in a mouse model of liver cancer. Additionally, CRV431 was as effective at decreasing tumor burden as an anti-PD1 antibody immune checkpoint inhibitor, PD1 antibody, and produced more beneficial changes in tumor infiltrating cells compared to anti-PD1 antibody treatment.
The study was conducted by FibroFind Ltd. (Newcastle, UK) in collaboration with Professor Derek Mann, Dean of Research and Innovation at Newcastle University. In this study, mouse hepatocellular cancer ("HCC") cells (hep53.4 cells) were surgically implanted into livers of recipient mice. In the absence of drug treatment, large tumors developed over a period of 28 days.
Drug treatments began in the treatment groups on Day 14 after HCC hep53.4 cell implantation, when the tumors had reached approximately 15% of their final size. Mice received either once-daily CRV431, administered orally, or a single dose anti-PD1 antibody, administered intraperitoneally. An additional treatment arm examined a CRV431/anti-PD1 antibody combination treatment. Drug dosing continued for a total of two weeks (Days 14 to 28 post-HCC implant) and the changes in tumor volumes were measured from the initiation of drug treatment to the end of the experiment. Treatment with CRV431 or an anti-PD1 antibody each decreased tumor size by 76%, while the CRV431/anti-PDI antibody combination treatment decreased tumor size by 83%, compared to the vehicle treatment (no drug).
Microscopic examination of the tumors showed that CRV431 beneficially doubled the number of tumor-infiltrating CD4 and CD8 lymphocytes. This same finding was observed with anti-PD1 treatment, suggesting that both treatments stimulated immunity against the tumors. Furthermore, CRV431 decreased the number of neutrophils in the tumors by 55%, which was not observed with anti-PD1 antibody treatment. Because neutrophil-mediated inflammation frequently promotes tumor growth, CRV431's demonstrated reduction in neutrophils represents an additional anti-tumor effect. Finally, a marker of cell proliferation indicated that both CRV431 and the anti-PD1 antibody decreased tumor cell proliferation to similar degrees. These results complement previously published findings of CRV431's anti-tumor activity in a different HCC model in which liver tumors developed spontaneously in mice with long-term, diabetes-associated, NASH-like disease.(1)
"CRV431 significantly decreased tumor burden in two distinct liver cancer models, suggesting that it exhibits anti-cancer activity across a range of HCC tumor subtypes and mutations," said Daren Ure, PhD, Hepion's Chief Scientific Officer. "It was also very encouraging to see that CRV431 positively altered inflammatory and immune cell populations in the tumors, which is a cornerstone of modern cancer therapy."
FibroFind CEO, Prof Jelena Mann, PhD, commented, "FibroFind is delighted with the outcome of this study, which indicates potential for CRV431 to bring about a reduction in tumour burden in what is an aggressive orthotopic model of liver cancer. The observation that CRV431 brings about a change in the neutrophil component of the tumour is particularly fascinating given the emerging role of this immune cell in many different cancers."
"HCC is the most common primary liver cancer, is often related to NASH, and is a leading cause of death worldwide," commented Robert Foster, PharmD, PhD, Hepion's CEO. "There is a constant and urgent need for new drug development to augment surgical interventions, including liver transplantation, when treating patients with HCC. The findings from this study bode well for the continued development of CRV431 as a drug candidate for treating liver diseases, including HCC and NASH. CRV431 targets the liver, and its anti-inflammatory and anti-fibrotic effects have been demonstrated in many liver disease models. More recently, CRV431 has shown positive changes in ALT and Pro-C3 in a 28-day NASH Phase 2a clinical trial, indicating its anti-inflammatory and antifibrotic effects. Having a single drug candidate with demonstrated beneficial activity in both NASH and HCC is quite remarkable and represents an opportunity for Hepion to further explore CRV431's potential in HCC while continuing to advance its clinical program in NASH."
Reference
(1) Kuo et al. A Pan-Cyclophilin Inhibitor, CRV431, Decreases Fibrosis and Tumor Development in Chronic Liver Disease Models, J. Pharmacol. Exp. Therap. (2019) 371(2):231-241; doi:10.1124/jpet.119.261099.
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(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 CRV431, 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 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
> Dow Jones Newswires
November 16, 2021 08:45 ET (13:45 GMT)
Lol 1.40. What a shitshow haha prs only drop this
Nice to see. This is going to be a long drag ‘‘em out journey. Hopefully the end result is all worth it.
Yes still here. Diamond hands
$1.36 cash + $0.11 science = $1.47 stock price
Market putting a big valuation on the science.
Still with us? 10q released today. 90 plus million in cash. Company and big hedgies playing games. Interesting times.
Shares selling for cash on B/S
Any decent pumpndump ought to be able to jack this to $2.50.
Business is for free, with solid data.
Cabal needs to get to work.
Have heard that before. Too many games being played by mgmt right now.
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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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