Van beleggers
voor beleggers
Uitgebreid zoeken

Beurscodes, betekenis en hulp bij zoeken

Europa

AEX
Euronext Amsterdam
BRU
Euronext Brussels
PSE
Euronext Paris
LIS
Euronext Lissabon
CHX
CBOE Europe, grote(re) EU aandelen
NAV
Investment Funds (NAV)

Noord-Amerika

NYS
New York Stock Exchange
OTC
CBOE BZX Exchange (US)
TSE
Toronto Stock Exchange

Kunt u een instrument niet vinden?

Zoek dan via de zogenaamde ISIN code. Elk instrument, aandeel etc. heeft een unieke code.

Kies vervolgens - wanneer er meerdere resultaten zijn - de notering op de beurs van uw keuze.

Waar vind ik die ISIN code?

Google de naam van het instrument, aandeel etc. met de toevoeging 'ISIN'.

Als zoeken op ISIN code geen resultaten oplevert hebben wij het instrument of aandeel niet in onze koersendatabase.

desktop iconMarkt Monitor
  • Word abonnee
  • Inloggen

    Inloggen

    • Geen account? Registreren

    Wachtwoord vergeten?
Home  /  Forum  /  BioPharma  /  NASH - bedrijven

Ontvang nu dagelijks onze kooptips!

word abonnee

BioPharma« Terug naar discussie overzicht

NASH - bedrijven

65 Posts
Pagina: «« 1 2 3 4 »» | Laatste | Omlaag ↓
  2. forum rang 10 DeZwarteRidder 19 september 2018 17:41
    Viking Therapeutics stock up after promising results for fatty liver drug
    By Cristin Flanagan Sep. 18, 2018

    Shares of Viking Therapeutics soared 87 percent Tuesday to close at $19.46 after the company said initial results for an experimental therapy for fatty liver disease exceeded investors’ expectations.

    Viking’s medicine, VK2809, cut the bad cholesterol, or low-density lipoprotein, as well as liver fat more than the placebo, the study showed. Ten milligrams of the therapy was shown by MRI to cut liver fat by 57 percent when taken every other day and by 60 percent when taken once a day. Results from the 12-week study of both doses showed liver fat was cut by roughly 30 percent or more in roughly 83 percent of patients, compared with 18 percent with the placebo.

    Shares of the San Diego company have soared in the past 12 months, climbing more than 750 percent as data from Madrigal Pharmaceuticals spurred the rally. Both companies are developing similar drugs belonging to the same class of liver-directed thyroid hormone receptor agonists.

    While Viking’s results were in non-alcoholic fatty liver disease, the company plans to move VK2809 forward in a more severe form of the disease known as non-alcoholic steatohepatitis, where there is also inflammation and liver damage, in addition to built-up fat in the liver, Chief Executive Officer Brian Lian said.

    The severe form of the disease, which is occurring more with ever-increasing rates of obesity, is expected to be a multibillion-dollar market, and drug companies are racing to find new treatments for the disease. Viking still needs to make a final report of the study results before talking to the Food and Drug Administration, which Lian expects to happen in the first half of 2019.

    The next step for Viking after clearing a plan with the agency will be a combined mid- to late-stage study where patients get liver biopsies at the beginning and end of the study.

    “Madrigal and others have shown that liver fat reductions seem to be similar across disease severity,” Lian said. He believes a study solely in non-alcoholic steatohepatitis patients will produce results similar to the current data.

    Meanwhile, comparisons to Madrigal’s results are already being made. Viking’s drug looks “best in class,” William Blair analyst Andy Hsieh wrote in a note to clients. While acknowledging the caveats of comparing across trials, he said VK2809 appears to be “numerically better” when compared with the up to 42 percent cut in liver fat from a separate mid-stage study of Madrigal’s drug. Madrigal shares dropped 9 percent to $207.30.
  5. Wil Helmus 24 september 2018 21:02
    Kom onderstaand stuk ook nog tegen op seekingalpha

    Expected Value Investing: Diving Deeper On Conatus

    Sep. 24, 2018 12:00 PM•CNAT

    SummaryConatus is currently valued at a market cap of $172.3M, significantly less than other firms engaged in NASH drug development.With a Phase 2 NASH cirrhosis data readout expected in Q4, Conatus has a significant catalyst on the horizon.Though Conatus' POLT-HCV-SVR trial produced mixed data, its lead drug candidate emricasan did demonstrate antifibrotic effects in certain patient subgroups.Conatus is alone in targeting decompensated NASH cirrhosis, the most severe and most expensive form of NASH cirrhosis.Based on a series of company-related assumptions, this article will analyze Conatus's expected financial value if emricasan receives FDA approval.

    After providing an overview of the NASH cirrhosis market in my most recent article, I'm now planning on further analyzing Conatus Pharmaceuticals (NASDAQ: CNAT), the only company in the entire NASH space targeting decompensated liver cirrhosis. After providing an overview of Conatus' lead drug candidate emricasan and its clinical progress thus far, I'll provide and calculate the expected value of an investment in Conatus and use this figure to determine whether the company's potential return outweighs the risk of speculation.

    Introducing Expected Value Investing

    As my more frequent readers know, most of my long ideas are speculative biotech stocks which offer a lopsided risk-reward profile. To identify these picks, I perform an expected value analysis as part of my general due diligence. After making a series of assumptions regarding the stock's predicted clinical and financial performance, I am able to forecast potential valuations for the company for both a bull scenario (drug approval/positive data) and a bear scenario (CRL/negative data). Then, I assign probabilities to both scenarios and compute the expected value of an investment in the company.

    Over the long term, I am confident that my expected value approach to investing is an effective method for generating sustained alpha. Granted, just because I have calculated that an investment should yield high expected value does not mean that the stock will perform - in the end, the stock's price is tied to the company's clinical progress. However, the expected value method can help investors pick potential big winners with uncharacteristically low downside. Going forward, I'm excited to present more of my ideas through the lens of expected value analysis.

    Emricasan - Method Of Action

    At present, doctors are unsure what exactly causes NASH to develop and progress in a patient. However, researchers have established a link between excessive apoptosis and NASH liver fibrosis and cirrhosis. Apoptosis is the process of genetically programmed cell death within the human body - when apoptosis occurs normally, old cells are killed off and absorbed by other cells through a process known as phagocytosis.

    Excessive apoptosis is associated with several different degenerative diseases (NAFLD and NASH included), while insufficient apoptosis can lead to cancer. In the liver specifically, excessive cell apoptosis leads to an accumulation of apoptotic bodies and cells, which then promotes fibrosis and eventual cirrhosis of the liver.

  6. Wil Helmus 24 september 2018 21:03
    Apoptosis is driven by proteins known as caspases. Research has shown that "caspase-3 and caspase-7 are activated by disease progression" of NASH and NAFLD; these caspases then cleave the protein cytokeratin-18 (CK18), creating a protein fragment called cCK18.

    This fragment is a biomarker of apoptosis, and elevated levels of cCK18 have been associated with NAFLD, NASH, and Hepatitis C. Emricasan is a pan-caspase inhibitor - it works to curtail excessive caspase-3 and caspase-7 activity, slowing the abnormally high rate of apoptosis (the initial cause of disease). Importantly, emricasan has no negative effect on apoptosis or caspase activity in healthy patients.

    Emricasan's Clinical Progress

    As of now, emricasan has completed one Phase 2 clinical trial, entitled POLT-HCV-SVR. POLT-HCV-SVR tested emricasan's ability to achieve fibrosis reduction (measured using Ishak fibrosis score) in post-orthotopic liver transplant patients who had achieved a sustained virologic response following successful antiviral Hepatitis C therapy. Unfortunately, for Conatus, the trial produced a mixed data readout. However, emricasan still has ample opportunity to prove itself, as Conatus is also evaluating emricasan in three other ongoing Phase 2 trials for NASH fibrosis and cirrhosis.

    POLT-HCV-SVR Results

    In April, Conatus announced that emricasan had missed its primary endpoint of liver fibrosis reduction in the POLT-HCV-SVR trial. After having experienced a significant run-up in the weeks prior, Conatus' stock dropped by almost a third in just a day. The market's reaction was somewhat justified; though the data (shown below) was not overtly negative, the fact remains that emricasan is still very much unproven.

  7. Wil Helmus 24 september 2018 21:05
    As the slide above shows, the study's data was somewhat skewed by emricasan's inability to have a positive effect on F6 fibrosis patients. However, as Conatus pointed out in its press release, emricasan demonstrated significant antifibrotic effects on F3-F5 patients - fibrosis reduction occurred in over 60% more patients treated with emricasan than with placebo.

    Despite this positive spin, the fact that emricasan was not able to have a meaningful effect on patients with F6 fibrosis is certainly a cause of concern, given that emricasan is primarily targeting patients at the latest stages of cirrhosis. Given this mixed data, it is difficult to forecast how emricasan will perform going forward - the only thing left to do is wait.
    As I mentioned previously, Conatus is currently in the midst of three other Phase 2 trials for emricasan:

    ENCORE-PH's upcoming data readout represents Conatus' most immediate catalyst. The study's primary endpoint is hepatic venous pressure gradient (HVPG) reduction in NASH patients with several portal hypertension, and is evaluating emricasan's ability to treat patients with compensated cirrhosis. Though it was difficult to get an idea of emricasan's actual potential from the POLT-HCV-SVR data, I believe that ENCORE-PH will provide investors with more definitive answers.

    Simply put, if emricasan fails to have a meaningful effect in reducing HVPG, it will be clear that the drug's clinical applicability is severely limited - and Conatus' stock price will reflect this. Additionally, poor performance in ENCORE-PH may also foreshadow to investors a less than positive readout for ENCORE-LF, Conatus' decompensated cirrhosis trial.

    ENCORE-NF, which is expected to read out in the first half of next year, is Conatus' NASH fibrosis trial. This trial is Conatus' least important clinical trial, given the current overcrowded state of the NASH fibrosis market. As such, a positive readout for ENCORE-NF will likely not have a major effect on Conatus' clinical progress or stock price.

    ENCORE-LF is Conatus' decompensated cirrhosis trial, and the results of this trial will have a major impact on the company's future. As a treatment for decompensated cirrhosis, emricasan's primary objective is to keep patients alive long enough for them to receive a potentially life-saving liver transplant. Thus, the primary endpoint of the trial is event-free survival at 240 weeks.

    If the company can achieve success in treating decompensated cirrhosis, it will be alone in that market. For this reason, failure in previous trials would not necessarily spell complete doom for Conatus. If emricasan shows efficacy against decompensated cirrhosis alone, the company has a blockbuster drug on its hands. Obviously, however, there would be significant risk surrounding the company in such a situation.

    Current Financial Health

    For the time being, Conatus is in an excellent financial position. At Q2 earnings, the company reported a balance of $57.7M in cash, cash equivalents, and marketable securities. Additionally, Conatus reported $13.5M in long-term debt and a net loss Q2 burn rate of $4.5M. At its current cash burn rate, management estimates that Conatus is funded through the end of 2019.

  8. Wil Helmus 24 september 2018 21:05
    Additionally, per a collaboration and licensing agreement with Novartis (NASDAQ: NVS) signed in December 2016, Conatus will not have to bear any of the burden of funding any future Phase 3 trials. Under the terms of the agreement, Conatus received cash, milestone payments, and clinical trial funding; Novartis received an option for exclusive rights surrounding the global development and commercialization of emricasan.

    In May 2017, Novartis announced that it had exercised its option. As a result, it is important to note for valuation purposes that Conatus now will only receive double-digit royalties on emricasan sales; the majority of revenue will pass to Novartis.

    Expected Value Analysis

    Valuation Assumptions

    In order to determine the valuation of Conatus if emricasan is approved, I first must estimate the drug's peak annual sales. Per my segmentation of the total NASH market, the NASH decompensated cirrhosis market alone will be worth $5.46B in 2025. If Conatus can get emricasan approved by 2023, I believe that the combination of massive unmet demand and Novartis' support will allow emricasan to meet 75% of that demand in 2025, representing annual revenue of $4.10B.

    Additionally, we must also consider emricasan's potential sales in the compensated cirrhosis market. Per my market segmentation, the compensated cirrhosis market will be worth $12.18B. If emricasan receives approval in 2023, it would potentially be the last entrant to that market behind Gilead's (NASDAQ: GILD) selonsertib and Galectin's (NASDAQ: GALT) GR-MD-02, assuming those two candidates are approved.

    Nevertheless, the massive market size means that there would likely be enough room for all three companies to operate comfortably. As such, I would estimate that emricasan could secure around 12.5% of that market - $1.52Bin annual sales. Given the saturation of the fibrosis market, I do not predict that emricasan will secure any meaningful amount of fibrosis sales. Overall, I predict that emricasan may be able to secure as much as $5.62B in sales by 2025.

    Next, let's assume a 10% discount rate and find the present value of Conatus' potential 2025 sales - this yields a 2025 cash inflow of $2.88B. Though I believe emricasan may have potential for much greater sales by the end of the decade, I'll assume for the sake of conservatism and to allow a significant margin of safety for any potential investment in Conatus that this number represents peak sales. To arrive at a final valuation, I'll apply a conservative peak sales multiplier of 2x.

  9. Wil Helmus 24 september 2018 21:06
    Per these calculations, Conatus' eventual potential valuation could be as high as $5.76B. If emricasan produces positive data in ENCORE-PH (or even ENCORE-LF), I would expect that the company's value might reasonably be calculated at one-fourth of that number - $1.44B. That being said, I would not expect Conatus to jump to that level immediately following a data readout - it will certainly take time for the company's stock to climb.

    On the other hand, if Conatus fails to produce positive data in ENCORE-PH, I would expect that the company's valuation would be cut at least in half, possibly dropping to around $60-75M in market cap. That said, sell-offs following poor data readouts are often excessive; over time, Conatus' price would likely somewhat recover from that low.

    Emricasan has demonstrated antifibrotic promise, but its effect on NASH cirrhosis - the drug's target market - is still unclear. I would thus assign the company a 35% probability of receiving a positive data readout in ENCORE-PH, and a 65% probability of mixed or negative data.

    Expected Value Calculation

    To make my calculations, I'll use the following probability assumptions (which I justified in the previous section):

    55% chance ENCORE-PH produces mixed/negative readout and market cap drops to $75M10% chance ENCORE-PH produces mixed/negative readout and market cap drops to $60M35% chance ENCORE-PH produces positive readout readout and market cap rises to $1.44B

    Expected Market Cap = (.55 x 75M) + (.10 x 60M) + (.35 x 1440M) = $551.2M

    This expected market cap is over three times Conatus' current value, and as such, I believe it is reasonable to conclude that the company is underpriced relative to its potential. Obviously, this is a speculative play, but from an expected value perspective, it makes sense - Conatus has the potential to be a massive winner. To demonstrate just how wide the margin of safety on Conatus is, I'll modify my calculations to be even more conservative - I'll assume that:

    60% chance ENCORE-PH produces mixed/negative readout and market cap drops to $75M12.5% chance ENCORE-PH produces mixed/negative readout and market cap drops to $60M27.5% chance ENCORE-PH produces positive readout readout and market cap rises to $1.00B

    Expected Market Cap = (.60 x 75M) + (.125 x 60M) + (.275 x 1000M) = $327.5M.

    Despite using a set of valuation assumptions which I would consider highly conservative, analysis predicts a 2x expected return. However, this analysis demonstrates that an investment in Conatus is still highly risky - there is not an enormous margin of safety if we use my second set of probability assumptions. Nevertheless, the high potential reward might justify investment for investors with a high risk tolerance.

  10. Wil Helmus 24 september 2018 21:07
    En het laatste deel:
    Personally, I am more inclined to believe that my first set of assumptions in the expected value analysis above is closer to reality. In fact, I actually believe that emricasan may have higher than a 35% probability of producing positive data. However, I chose to perform my analysis through the lens of extreme conservatism, and Conatus held up to the test - the company offers a 2x expected return and a potential future valuation nearly six times higher than the company's current market cap.

    Risks

    Like any other clinical-stage biotech company, CNAT holds significant risk as an investment. The company's success depends almost entirely on emricasan and its trial results. Though the company is currently conducting three trials, the trials testing emricasan's effectiveness against NASH cirrhosis are the most important. Should these trials fail to achieve positive results, CNAT will likely be in a tight spot - even if emricasan performs well against NASH fibrosis, the intense competition in that space will make it quite difficult for CNAT to break into that segment of the market, even with the help of NVS.

    Another major risk for most clinical-stage biotech companies is that the company may not be able to commercialize its drug once it manages to win approval. However, with its collaboration agreement with NVS, CNAT has managed to alleviate this risk substantially - that said, the risk is still present.

    Conatus - High Risk, Higher Reward

    Speculative biotech is about picking big winners and small losers, and I think Conatus fits that profile well. As I mentioned above, Conatus could drop by 50% if ENCORE-PH does not produce positive data, but I believe this risk is worth it for the multibagger potential the stock provides. In the end, investment in Conatus comes down to each investor's individual risk profile - hopefully, those who choose to take the plunge are rewarded.

  11. Wil Helmus 1 oktober 2018 15:27
    Oppenheimer is maintaining its Buy rating and $14 price target on small NASH concern Conatus Pharmaceuticals (CNAT) this morning. Here is the analyst commentary from that call.

    CNAT held a KOL event focused on Portal Hypertension (NYSE:PH) ahead of the 4Q18 top-line data from the Ph2 ENCORE-PH study. Dr Garcia-Tsao (Yale) highlighted the high burden from cirrhosis and fact that PH is the driving factor in progression from compensated to decompensated cirrhosis, which leads to severe morbidity and high risk of mortality. There is a significant unmet need in PH where current therapies are mostly symptomatic. Non-selective beta-blockers (NSBBs) are the only agents reducing PH and meta-analyses show a translation into outcomes underlining the significance of lowering PH. Dr. Bosch (Barcelona) explained the increase in PH is related to increased inflow (targeted by NSBBs) but mainly driven by liver resistance, which is targeted by emricasan."
  12. Wil Helmus 3 oktober 2018 15:14
    GILEAD'S FXR AGONIST AMONG NASH THERAPIES HIGHLIGHTED AHEAD OF
    AASLD
    BY BRIAN MOY
    Abstracts with Phase II data for several non-alcoholic steatohepatitis therapies were published ahead of next
    month's American Association for the Study of Liver Diseases meeting in San Francisco.
    Among them, Gilead Sciences Inc. (NASDAQ:GILD) reported new data for GS-9674, its non-steroidal agonist of
    farnesoid X receptor (FXR; NR1H4).
    In a Phase II trial in 140 non-cirrhotic patients, Gilead said once-daily oral GS-9674 significantly reduced median
    liver fat content from baseline to week 24 by 1.8% at the 30 mg dose (p=0.029) and by 22.7% at the 100 mg dose
    (p<0.001) vs. an increase of 1.9% for placebo. Additionally, a significantly greater proportion of patients in the
    high-dose GS-9674 arm achieved a reduction in liver fat of at least 30% vs. placebo (38.9% vs. 12.5%, p=0.011). The
    company also reported a higher incidence of moderate to severe pruritus with high-dose GS-9674 (14.3%)
    compared with low-dose GS-9674 (3.6%) and placebo (3.6%).
    Abstracts from Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) and Viking Therapeutics Inc. (NASDAQ:VKTX)
    highlighted previously reported data for the companies' respective selective thyroid hormone receptor ß agonists.
    The companies will report updated data at AASLD.
    On May 31, Madrigal jumped 145% to $265.61, gaining over $2.2 billion in market cap, after reporting 36-week data
    from a Phase II trial of MGL-3196 to treat liver biopsy-confirmed NASH. Those data showed MGL-3196 led to
    sustained, significant mean relative reductions in liver fat at week 36 (37% vs 8.9% for placebo, p<0.0001) (see
    "Big Gain for Madrigal on 36-week NASH Readout").
    On Sept. 18, Viking added 87% to $19.46, an increase of over $550 million in market cap, after reporting data from
    a Phase II trial of VK2809 to treat non-alcoholic fatty liver disease (NAFLD). VK2809 significantly reduced median
    liver fat content from baseline to week 12 by 59.7% at the daily dose and by 56.5% at the every other day dose vs.
    8.9% for placebo (p<0.01 for both). Additionally, a significantly greater proportion of patients in both VK2809
    arms achieved a reduction in liver fat of at least 30% vs. placebo (90.9% and 76.9%, respectively, vs. 18.2%, p<0.01
    and p=0.012) (see "Viking Gains on Phase II NAFLD Data").
    Liver fat content in all three Phase II trials was measured by MRI proton density fat fraction (MRI-PDFF), an
    imaging-based endpoint that could replace biopsies in clinical trials (see “New Endpoints in NASH”).
    Gilead is also developing selonsertib, an apoptosis signal-regulating kinase 1 (ASK1; MAP3K5) inhibitor, to treat
    NASH. The company expects data in 1H19 from the Phase III STELLAR 3 and STELLAR 4 trials of selonsertib in the
    indication.
    On its 2Q earnings call in July, Gilead disclosed that it discontinued selonsertib's development to treat severe
    alcoholic hepatitis after the compound missed the primary endpoint of improving mortality in a Phase II trial in the
    indication. In an abstract released ahead of AASLD, the company reported that the 28-day mortality rate in the
    selonsertib arm of the trial was 4.3% (2/47) vs. 4% (2/50) in the placebo arm. At week eight, the mortality rate
    increased to 20.5% (9/44) in the selonsertib arm vs. an increase to 6.1% (3/49) in the placebo arm. Among the 12
    patients who died, Gilead said seven were female and had a baseline Model for End-Stage Liver Disease (MELD)
    score of >21 points. Patients received prednisolone in combination with selonsertib or placebo daily for 28 days.
    Madrigal has exclusive, worldwide rights to MGL-3196 from Roche (SIX:ROG; OTCQX:RHHBY). Viking has rights to
    VK2809 from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), which was down $4.02 to $268.11 on Tuesday.
    Gilead was up $0.71 to $78.67; Madrigal lost $2.18 to $210.08; and Viking was off $0.97 to $15.94.
  19. Wil Helmus 4 november 2018 19:24
    Komt Conatus komende vrijdag tijdens de Liver Meeting in San Francisco met de resultaten Encore PH?
    FRIDAY (11/9):
    Conatus Pharmaceuticals (NASDAQ:CNAT): Data on emricasan and IDN-7314.

    Ik vind Viking Therapeutics trouwens ook erg interessant. Lieten goede resultaten zien voor fase 2 VK2809 waarmee ze concurrent Madrigal overklasten. En ze hebben met VK5211 nog een potentiële blockbuster in huis
  20. Dr. Bob 5 november 2018 00:42
    quote:

    Wil Helmus schreef op 4 november 2018 19:24:

    Komt Conatus komende vrijdag tijdens de Liver Meeting in San Francisco met de resultaten Encore PH?
    FRIDAY (11/9):
    Conatus Pharmaceuticals (NASDAQ:CNAT): Data on emricasan and IDN-7314.
    Zou zo maar kunnen. Er was afgelopen vrijdag verdacht veel omzet.
65 Posts
Pagina: «« 1 2 3 4 »» | Laatste |Omhoog ↑

Meedoen aan de discussie?

Word nu gratis lid of log in met je emailadres en wachtwoord.

Direct naar Forum

Indices

AEX 874,79 +0,96%
EUR/USD 1,0702 +0,47%
FTSE 100 8.044,81 +0,26%
Germany40^ 18.161,70 +0,13%
Gold spot 2.322,53 -0,20%
NY-Nasdaq Composite 15.696,64 +1,59%

Stijgers

VIVORY...
+26,32%
BAM
+4,73%
PROSUS
+3,52%
ASMI
+3,14%
JUST E...
+3,10%

Dalers

RANDST...
-7,22%
Akzo N...
-6,93%
FASTNED
-4,65%
NSI
-3,89%
Arcelo...
-2,65%

Lees verder op het IEX netwerk Let op: Artikelen linken naar andere sites

Gesponsorde links

Meld u aan voor de dagelijkse Beursupdate

Dagelijks een update van het laatste beursnieuws en beleggingskansen in uw mailbox!