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Viking Therapeutics (VKTX) succes met NASH..?

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  1. forum rang 10 DeZwarteRidder 21 maart 2019 20:41
    Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders.

    Viking’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, including non-alcoholic steatohepatitis (NASH). In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company is also developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD).

    Viking’s other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared with patients who received placebo. Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
  2. forum rang 10 DeZwarteRidder 29 maart 2019 18:50
    Short Target Viking Therapeutics Wins Over Only Cautious Analyst
    By Cristin Flanagan
    29 maart 2019 14:47 CET


    Short-seller target Viking Therapeutics Inc. got a boost from Wall Street on Friday as the only cautious analyst upgraded the stock to a buy.

    Viking shares climbed as much as 5.8 percent in New York after SVB Leerink analyst Pasha Sarraf raised his rating to outperform from market perform and more than doubled his 12-month price target to $21 from $10. All nine analysts tracked by Bloomberg now recommend buying shares even as bearish bets on Viking have risen to 47 percent of the available float, according to data from financial analytics firm S3 Partners.
    Viking shares beaten back from highs as shorts circle

    The drugmaker is among companies racing to introduce the first treatments for the fatty liver disease known as NASH. Sarraf, who started covering the stock in February, said data this week that showed a low dose of Viking’s drug worked at least as well as higher doses were “persuasive.” The company will probably start a mid-stage study in NASH with “minor to no restrictions on who they will be allowed to study,” he said.
  3. Wil Helmus 31 maart 2019 20:02

    George Budwell (Viking Therapeutics): The market hasn't been kind to the clinical-stage biotech Viking Therapeutics over the last few months. Even though the company's nonalcoholic steatohepatitis (NASH) drug candidate VK2809 hit the ball out of the park in its midstage trial late last year, Viking's shares have somehow lost nearly 60% of their value since this top-line data release.

    Adding to the mystery, Gilead Sciences reported a late-stage flop in NASH last year, and Intercept Pharmaceuticals' Ocaliva didn't exactly blow the investing community away with its mixed NASH results, either. Put simply, Viking still has a decent shot at bringing one of the first needle-moving therapies to market for this high-value indication. Yet investors have chosen to overlook this promising biotech stock.

    What gives? Viking's shares are being weighed down by the fact that VK2809 remains a few years away from entering a pivotal stage trial for NASH. Later this year, the company plans on advancing VK2809 into a phase 2b trial to evaluate its clinical benefit in patients with biopsy-confirmed NASH. This next trial is expected to take up to a year to complete, which will put Viking well behind the leaders in the field in terms of clinical development.

    Even so, the market seems to be severely underestimating this particular NASH candidate. While there is certainly a need for more data, VK2809's emerging clinical profile easily puts it in the running for a best-in-class designation. As such, Viking's latecomer status may not ultimately matter from a commercial standpoint.

    The bottom line is that Viking currently offers a level of deep value rarely found in the healthcare sector, thanks to its aspirations in NASH. That said, this is a pre-revenue biotech stock -- meaning that investors should carefully mull over Viking's risk-to-reward ratio before buying shares.

  4. Wil Helmus 2 april 2019 15:00

    Our Stock of the Week is Viking Therapeutics (VKTX). The company is developing a number of therapies for the treatment of metabolic and endocrine disorders, but what is of most immediate interest is its drug for the treatment of non-alcoholic steatohepatitis (NASH).

    The company has had strong results but has been in a consistent downtrend since announcing results in September of last year. The stock has been languishing in the $7.00-8.50 range since December, but it has finally turned up following news that its drug worked effectively with a smaller dose. There have been concerns about safety, and this helped to ease the worries.

    In response to the news, analysts at Leerink upgraded the stock to outperform with a target of $21. The latest data is scheduled to be presented on April 11, which should help to provide support for the stock.

    The stock has been heavily shorted, but this shift in the technical conditions along with the positive data should push shorts to cover.

    As always, we would not chase the stock higher at the open on Monday but would look for entries either on lower volume pullbacks or sustained strength on high volume. There is support in the $9.25 area, which technicians will be watching.

  5. forum rang 10 DeZwarteRidder 4 april 2019 10:57

    Wil Helmus schreef op 4 april 2019 09:31:


    EASL 2019 preview – Viking and Spring Bank abstracts pique early interest
    Viking in particular caused something of a stir with data on VK2809, a thyroid hormone receptor beta agonist that counts as one of the sector’s most closely watched Nash projects.

    An abstract on a phase II trial contained the first data seen with a low 5mg dose of VK2809, suggesting that this could be as effective as 10mg, with obvious safety advantages. Leerink analysts wrote that should this be confirmed in larger studies, VK2809 could be a best-in-class compound.
  6. Wil Helmus 5 april 2019 13:52
    WEDNESDAY (4/10): European Association for the Study of the Liver (EASL), Vienna (5 days).
    Viking Therapeutics (NASDAQ:VKTX): Phase 2 data on low-dose VK2809 in NASH. 
  7. forum rang 10 DeZwarteRidder 8 april 2019 19:55

    Wil Helmus schreef op 8 april 2019 19:51:

    Viking Therapeutics (NASDAQ:VKTX) Earns “Outperform” Rating from William Blair

    Posted by John Adams on Apr 7th, 2019 // No Comments

    Viking Therapeutics Inc logoWilliam Blair reissued their outperform rating on shares of Viking Therapeutics (NASDAQ:VKTX) in a research note released on Thursday, March 14th, Stock Target Advisor reports.

    Several other research firms have also recently weighed in on VKTX. Svb Leerink began coverage on Viking Therapeutics in a research report on Friday, February 22nd. They set a mkt perform rating on the stock. Raymond James upgraded Viking Therapeutics from an outperform rating to a strong-buy rating and set a $43.00 price objective on the stock in a research report on Monday, November 19th. They noted that the move was a valuation call. Leerink Swann started coverage on Viking Therapeutics in a research report on Friday, February 22nd. They issued a market perform rating and a $10.00 target price for the company. BidaskClub upgraded shares of Viking Therapeutics from a strong sell rating to a sell rating in a research note on Wednesday, January 2nd. Finally, Maxim Group lowered their price target on shares of Viking Therapeutics from $28.00 to $20.00 and set a buy rating on the stock in a report on Thursday, March 14th. One investment analyst has rated the stock with a sell rating, nine have issued a buy rating and two have assigned a strong buy rating to the company’s stock. Viking Therapeutics presently has an average rating of Buy and an average target price of $22.54.
    Get Viking Therapeutics alerts:

    Viking Therapeutics stock traded up $0.31 during trading on Thursday, hitting $10.63. The stock had a trading volume of 2,377,428 shares, compared to its average volume of 4,301,267. The company has a market cap of $765.21 million, a price-to-earnings ratio of -26.58 and a beta of 2.75. Viking Therapeutics has a 1 year low of $3.69 and a 1 year high of $24.00.

    Viking Therapeutics (NASDAQ:VKTX) last released its earnings results on Wednesday, March 13th. The biotechnology company reported ($0.07) earnings per share for the quarter, beating analysts’ consensus estimates of ($0.10) by $0.03. Equities analysts anticipate that Viking Therapeutics will post -0.47 earnings per share for the current year.

    Hedge funds and other institutional investors have recently modified their holdings of the stock. Zurcher Kantonalbank Zurich Cantonalbank acquired a new stake in Viking Therapeutics in the 4th quarter worth approximately $30,000. Lindbrook Capital LLC bought a new position in shares of Viking Therapeutics during the 4th quarter worth approximately $36,000. Quantbot Technologies LP bought a new position in shares of Viking Therapeutics during the 3rd quarter worth approximately $109,000. Great West Life Assurance Co. Can acquired a new position in shares of Viking Therapeutics during the 4th quarter worth approximately $53,000. Finally, Meeder Asset Management Inc. increased its holdings in shares of Viking Therapeutics by 63.5% during the 4th quarter. Meeder Asset Management Inc. now owns 7,309 shares of the biotechnology company’s stock worth $56,000 after acquiring an additional 2,839 shares during the last quarter. Institutional investors and hedge funds own 65.31% of the company’s stock.
  8. Wil Helmus 9 april 2019 10:19
    'De markt' heeft er nog weinig vertrouwen in. De koers is niet vooruit te branden. Erg belangrijk dat de goede resultaten in grotere studies worden bevestigd
  9. Wil Helmus 11 april 2019 20:21
    "Seven of nine patients getting Viking’s VK2809 at a dose of 5 milligrams once a day saw their liver fat cut by 50 percent or more. The biggest reduction in liver fat at the 5 milligram dose was 78 percent, according to data presented at the European Association for the Study of the Liver congress in Vienna. The company is also testing a 10 milligram dose. No serious side effects have been seen from the treatment to date."

    “There were no red flags” around liver safety and “cross-trial comparisons suggest that VK2809 has the better profile” compared to Madrigal Pharmaceuticals Inc.’s competing resmetirom, Bloomberg Intelligence analyst Michael Shah wrote in a note.


  10. Wil Helmus 13 april 2019 15:28
    EASL 2019 – Viking to push the limits of its Nash contender

    Encouraging results from Viking Therapeutics’ lead Nash project have prompted the company to ask how low it can go.

    Encouraging signs of efficacy with Viking Therapeutics’ thyroid receptor antagonist VK2809 are emboldening the company to examine whether the compound’s therapeutic window can be pushed open even wider.

    At EASL today the group presented impressive reductions in liver fat in patients dosed with 5mg of VK2809 once daily; this was the lowest dose tested in a recently completed phase II study that also included 10mg given either once a day or once every other day. Responses were similar across the dose groups.

    Viking shares have risen 19% since the 5mg data were first disclosed in EASL abstracts two weeks ago, and opened up 6% in today. Thyroid receptor antagonists have been associated with bone and cardiovascular safety issues, so hints that VK2809 could maintain its efficacy even at low doses are encouraging. Some in the sellside have suggested that VK2809 is starting to look like a best-in-class compound.

    Although the 5mg daily and 10mg every other day doses would lead to a similar exposure to VK2809, the 5mg daily dose would produce lower peak levels of the drug, so could be safer.

    Speaking at a poster presentation at EASL, Brian Lian, Viking’s chief executive, told Vantage that the company wanted to take the dosage even lower in phase IIb; a study is slated to start in the second half of the year.

    “There are no obvious reasons to go higher than 5mg,” he said. He would not disclose how low the company might go, but suggested that 2.5mg was not an unreasonable assumption.

    He speculated that a lower dose could mean weaker efficacy on plasma markers like LDL cholesterol, but he expects measures like liver fat reduction to hold up.

    Mr Lian said that Viking was very pleased with the safety readings from the phase II study, which threw up little of concern. 59 patients with non-alcoholic fatty liver disease and high cholesterol were recruited; the trial will have included some Nash patients, he said, though because they were not biopsied firm numbers could not be confirmed.

    This will be the focus of the phase IIb study, which will recruit biopsy-confirmed Nash patients; the company has previously said this would enrol 150 patients at a minimum, and would probably last for 12 months. It will select for patients with stage 2 and 3 fibrosis, with a capped number of stage 1 subjects.

    Results from this study will be required as a more definitive confirmation of VK2809’s profile, which is being held up against MGL-3196, a similar compound being developed by Madrigal (AASLD 2018 – Viking lands blow in early Nash skirmish, 13 November 2018).

    Madrigal is substantially further ahead here, having recently started a large, 2,000-patient phase III trial. But these new data from Viking show that this is far from a one-horse race.

  11. forum rang 6 Hulskof 16 april 2019 14:35

    Wil Helmus schreef op 9 april 2019 10:19:

    'De markt' heeft er nog weinig vertrouwen in. De koers is niet vooruit te branden. Erg belangrijk dat de goede resultaten in grotere studies worden bevestigd
    Dat komt misschien hierdoor:

    Mean absolute % change in liver fat by MRI-PDFF wasn't terribly impressive, -10% in the drug group, which sort of invalidates what VKTX says below:

    ""The liver fat reductions produced by low-dose VK2809 are impressive and may suggest improvement in histology in longer-term biopsy-based studies. ==>Our research suggests that reducing liver fat by 30% or more increases the likelihood of a potential histologic response in NASH patients.<== Since more than two-thirds of patients receiving VK2809 demonstrated at least a 50% reduction in liver fat we would expect a potentially higher likelihood of improved liver histology," stated Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center, and Professor of Medicine, University of California at San Diego. "These robust improvements in liver fat content, combined with reductions in plasma lipids such as LDL-C suggest a potential cardioprotective benefit in these patients, which would represent a promising and novel profile." "

    Relative reduction of liver fat was > 30%, but absolute reduction was not, so nothing above really applies to their results. Also, where are results for TG and LDL-C levels for the 5 mg/day group? They've only released LDL-C reductions for 10 mg group - must not be terribly impressive for 5 mg group. Lastly, this P2 trial only had 45 total patients (12 control), and they had dropouts - makes me question results because such a low number of patients were studied. Appears VKTX is withholding quite a bit of data, stuff that if good they'd be shouting from the rooftops about.

    Bovenstaand is een reactie van iemand op Seeking Alpha. Ik weet niet in hoeverre alles klopt wat hij/zij zegt, maar er kan een kern van waarheid in zitten.
  12. Wil Helmus 16 april 2019 20:35
    Ik denk dat dat niet het probleem is. Vergelijk viking maar eens met Madrigal, de andere thyroid hormone receptor agonist voor de behandeling van NASH. Dan doet viking het gewoon beter. Zie bijlage. Er is momenteel nog veel onzekerheid. En daar maken shorters handig gebruik van
  13. Wil Helmus 16 april 2019 22:13
    Hmm ik kom dit stukje tegen op seekingalpha:

    VK2809 does not have biopsy data yet, so with current evidence, there is no way that VK2809 can compete with MGL-3196. Besides, VK2809 has an earlier patent expiration of 2024, which greatly reduces its potential.

  14. forum rang 6 Hulskof 17 april 2019 07:35
    Dat eerste wist ik, dat laatste niet. Lijkt me vrij cruciaal eigenlijk. Als dit waar is, lijkt het me eerder tijd om uit te stappen dan om bij te kopen...
  15. Wil Helmus 19 april 2019 20:19
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    4 Easter Biotech Picks From Analysts

    Apr. 19, 2019 8:42 AM

    Socialist: A man suffering from an overwhelming conviction to believe what is not true." - H.L. Mencken

    I hope the entire SA community has a long and relaxing holiday weekend planned.  I also hope investors have a much better week upcoming in the biotech sector which was shellacked late this week.  The increasing calls for 'Medicare for All' as the 2020 election process starts in earnest and a bout of algorithmic trading programs hit this high beta part of the market hard this week.


    Late Thursday a couple of analysts put out some positive commentary about specific biotech stocks.  Here are four that got 'shout outs' before the Easter weekend.

    Oppenheimer maintains its Buy rating and $28 price target on Corbus Pharmaceuticals (CRBP) and provides the following view around recent events at the company.

    We are gratified to learn of CRBP’s plan to revise the primary endpoint of lenabasum’s Phase 3 RESOLVE-1 trial in systemic sclerosis to wk 52 ACR CRISS from mRSS following FDA discussions, for several reasons: (1) a statistically-significant improvement on CRISS was met in the Phase 2 study and was its primary endpoint; (2) it may be more sensitive to clinically meaningful treatment changes; (3) as a composite outcome measure, it likely better captures SSc’s sign/symptom complexity; (4) several recent Phase 3 SSc trials succeeded on CRISS whereas they missed on mRSS; and, (5) the CRISS has been provisionally endorsed by the ACR. Top-line data remain on track for mid-2020, and we agree with CRBP that probability of success is increased. We reiterate our Outperform rating.”

    Biomarin Pharmaceuticals (BMRN) gets some nice support from Piper Jaffray who reaffirmstheir Buy rating and $120 price target.  Piper's analyst states  'The bear thesis on the June 6 Valrox Phase 2 year three update readout "simply does not hold water,".  The bear thesis centers around management seeing regular updates to the data, but the company took pains to explain the blinding protocols in place and insist it has been blinded since the two year update and believes management and remains a buyer of BioMarin shares.' The analyst sees 'the controversy around the data as a "bit of a tempest in a teapot," and he urges investors to "stay the course."

    10 Simple Rules To Trade Options Like A Pro' from our friends at Investors Alley is a good quick overview on using option strategies to mitigate risk and enhance returns in your portfolio. These strategies are well suited to high beta sectors like biotech where option premiums tend to be large. The report is now available free via download HERE

    Next up is Fortress Biotech (FBIO) which got a boost late in the week thanks to its stake in Mustang Bio (MBIO).  H.C. Wainwright took the opportunity to reiterate its Buy rating and $11 price target late Thursday with the following commentary.

    Valuation and risks to price target achievement. We reiterate our Buy rating and $11 price target. Our valuation is based on our clinical net present value (NYSE:NPV) model, which derives value from across Fortress’ subsidiaries. This model allows us to flex multiple assumptions affecting a drug’s potential commercial profile. Factors which could impede reaching our price target include failed or inconclusive clinical trials or inability of the company to secure adequate funding to progress its drugs through the development pathway.”
    Finally, a different analyst at Wainwright likes Viking Therapeutics (VKTX).  He reissued his Buy rating and $31 price target Thursday and provided some reasons for his optimism.

    Valuation and risks to price target achievement. We reiterate our Buy rating and $31 price target. Our peak sales estimates for VK2806 and VK5211 are based on our U.S. projections, and believe overall that peak sales could be conservative because of the size of the addressable markets, the continuing unmet medical need, and no projections for ex-U.S. sales currently. Our price target is based on our clinical net present value (NPV) model, which allows us to flex multiple assumptions affecting a drug’s potential commercial profile.”


  16. forum rang 6 Hulskof 20 april 2019 19:14
    Viking lijkt een jaar of 6 achter te liggen op Madrigal en vooral Intercept. Vooralsnog lijkt VK2809 superieur, maar afwezigheid van biopsie data is een zwak punt en zorgt voor vraagtekens.
    Hoe groot schat jij, Wil Helmus, de kans op een overname of samenwerking met een grote jongen die de zaak voor Viking flink zou kunnen versnellen? Is dat hetgeen waarop wij aandeelhouders moeten hopen de komende maanden? Ik zie het aandeel de komende tijd, gezien het hoge shortpercentage, anders alleen maar verder dalen... Wat is wijsheid...
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