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Home  /   Forum   /   Amerikaanse aandelen   /   Viking Therapeutics (VKTX) succes met NASH..?

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Viking Therapeutics (VKTX) succes met NASH..?

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78 Posts
Pagina: «« 1 2 3 4 | Laatste | Omlaag ↓
  2. forum rang 10 DeZwarteRidder 15 augustus 2019 15:00
    quote:

    Hulskof schreef op 15 augustus 2019 14:03:

    Viking Therapeutics: A Potential NASH Blockbuster seekingalpha.com/article/4285176?sour... $VKTX
    Opinion

    VKTX is trading in the low $7s right now and presents a very interesting opportunity to investors to take a position in a promising NASH drug candidate with a long-tailed pipeline. If the company starts the new phase 2b trial, this stock will shoot up. Given its cash position and trial data, there’s no reason - barring absolutely criminal ones - why that would not happen anytime soon.

    Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.

    That means that when the catalyst comes that will make or break a stock, we've positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.
  5. sp1946 18 augustus 2019 19:10
    Viking Therapeutics (VKTX) are testing medicines known as THR agonists.

    Obesity Epidemic Leads To A New Problem — And It Could Be Worth Billions
    • ALLISON GATLIN
    • 8/16/2019
    The obesity epidemic in the U.S. is leading to a new problem for doctors.
    By 2020, a liver disease known as nonalcoholic steatohepatitis, or NASH, will be the leading cause of liver failure. That will lead to more liver transplants in the U.S., experts say.
    A cadre of biotech companies — led by Intercept Pharmaceuticals (ICPT) and Genfit (GNFT) — believe they each have a solution to what could be a several-billion-dollar problem. Estimates vary widely, but some say the opportunity for a NASH liver disease drug could be $50 billion or more.
    "It's already overtaken alcoholic liver disease and it's about to overtake hepatitis C (as the leading cause of liver transplants)," Intercept Chief Executive Mark Pruzanski told Investor's Business Daily. "It really is an epidemic. It's not just one confined to the U.S. The Western diet and lifestyle is pervasive globally. So this is a burgeoning disease around the world."
    nd today there's no approved treatment for NASH liver disease, said Pruzanski, whose biotech company is seen grabbing the first Food and Drug Administration approval in 2020.
    This liver disease is an epidemic, he said.
    NASH Liver Disease Is Hard To Diagnose
    NASH liver disease is a progression of fatty liver disease. In these patients, fat accumulates in the liver, causing inflammation and eventually scarring. This differs from fat accumulation due to heavy alcohol use, which is called alcoholic liver disease.
    The National Institutes of Health estimates 30%-40% of adults in the U.S. have a fatty liver. Of those, about 20% have NASH liver disease.
    But liver disease treatment is complicated, especially in the case of NASH. First, patients with NASH generally don't have symptoms until their livers become extensively scarred — a condition known as cirrhosis. By then, most experts say, the patient is too sick for anything but a transplant.
    Second, the only way to confirm NASH liver disease is through a costly liver biopsy.
    Third, without a targeted liver disease treatment, there's no reason to perform a liver biopsy, JMP Securities analyst Liisa Bayko said in an interview. A liver biopsy involves a large needle pushed through the abdomen to grab a piece of the liver. It can be complicated and painful.
    "There's no reason to be diagnosed because there's nothing to be done about it," she said. "Once there's a solution, physicians are motivated to try to find the patients because they have something to offer. If there's nothing to offer them, there's no point in diagnosing them."
    Specific Guidelines For Approval Of NASH Liver Disease Drug
    The Food and Drug Administration has specific guidelines for biotech companies exploring NASH liver disease treatments.
    Most biotech companies are looking to treat patients with fibrosis, a form of scarring in the liver. Doctors measure fibrosis in stages. The worst level of fibrosis is stage 4. Healthier patients have a lower stage of fibrosis. Cirrhosis is a more serious form of scarring in the liver.
    In order to gain approval, a company must show its treatment can improve fibrosis by at least one stage. Meanwhile, NASH symptoms must not worsen at the same time. Or, a biotech company can resolve NASH completely. But fibrosis must not increase. They must do this in stage 2 and stage 3 patients.
    So far, only one biotech company has shown that: Intercept. In a Phase 3 study, the company's drug — dubbed obeticholic acid, or OCA — improved fibrosis by one stage over 18 months. Meanwhile, patients didn't show worsening symptoms of NASH.
    Genfit Could Follow Intercept With Approval
    Now, Intercept is planning to ask the FDA to approve OCA in NASH liver disease treatment in the third quarter. The biotech company is also planning to file for European approval in the fourth quarter, CEO Pruzanski said. He expects to launch the drug in 2020.
    Genfit could follow. It's the only other biotech company with an experimental drug for NASH in Phase 3 testing. Genfit is studying a medicine called elafibranor in patients with stages 2-3 fibrosis. It's due to have the results of that study by year-end.
    "When elafibranor gets on the market about the same time as OCA, the next drug will not get on the market for at least another three years," Genfit Chief Operating Officer Dean Hum said in an interview. "So having that time advantage is going to be very important."
    Gilead Sciences (GILD) started the year with a potential NASH liver disease treatment in late-stage testing. Gilead looked at the drug, selonsertib, in patients with stage 2-3 fibrosis and cirrhosis. In both cases, the drug failed.
    Biotech Companies Rush To The Finish Line
    Intercept also sells OCA under the brand name Ocaliva as another liver disease treatment. It's known as an FXR agonist. These drugs regulate bile acid, lipid and glucose metabolism. But industry watchers associate them with itching and raising "bad" LDL cholesterol.
    Genfit's elafibranor targets a substance called PPAR. The biotech company believes it can resolve NASH liver disease completely. Further, elafibranor has shown a penchant for cutting LDL cholesterol and lipids, boosting insulin sensitivity and lowering the risk of cardiovascular events.
    SVB Leerink analyst Pasha Sarraf acknowledged Intercept will likely grab the first approval in NASH liver disease treatment. But patients who take Ocaliva will have to "stack" other medicines to keep their LDL cholesterol in line, he said.
    "Why do you have to sort 15 different drugs just to tolerate Ocaliva?" he said in an interview. "As new drugs become available, I expect the opportunity for Intercept will start being competed against and their opportunity will diminish."
    Challenges Face Biotech Companies In NASH
    Meanwhile, Genfit is also facing its own doubters. In mid-June, rival biotech company CymaBay Therapeutics (CBAY) offered a disappointing look at its PPAR drug in a Phase 2b study. In that study, reductions in liver fat remained minimal and insignificant compared with a placebo.
    "These data raise the risk for Genfit whose drug, elafibranor, is also a PPAR and we believe already had a low likelihood of success on NASH resolution in its upcoming year-end 2019 Phase 3 readout," RBC Capital Markets analyst Brian Abrahams said in a June report.
    Part of the challenge? Experts don't agree on what causes NASH. It can take decades for a fatty liver to become inflamed. From there, patients can develop fibrosis and cirrhosis more rapidly.
    "NASH is silent until it gets very advanced," JMP analyst Bayko said. "Then it's too late."
    Biotech companies like Madrigal Pharmaceuticals (MDGL) and Viking Therapeutics (VKTX) are testing medicines known as THR agonists. These drugs control the metabolism of fat in the liver. By lowering liver fat, Madrigal hopes to resolve NASH.
    Madrigal's midstage study found that upon NASH's resolution, patients show a 61% reduction in fibrosis, says Rebecca Taub, the biotech company's chief medical officer and executive vice president of research and development.
    "We think this also demonstrates the importance of treating the underlying cause," she said in an interview. "Fibrosis is just a reaction to the NASH. Take that away, then the fibrosis will improve."
  6. sp1946 18 augustus 2019 19:19
    Initiation of Phase 2b NASH trial planned in 2H19.

    Pre-IND package submitted for VK2809; Initiation of Phase 2b NASH trial planned in 2H19.
    The company recently submitted a pre-investigational new drug (pre-IND) meeting briefing package to the Food and Drug Administration (FDA) for VK2809 and expects to receive written feedback from the agency in the coming weeks. A new IND is required as the existing IND is filed with the FDA's Division of Metabolic and Endocrinology Products, while most NASH drugs are reviewed in the Division of Gastroenterology and Inborn Errors Products. The company expects to file an IND application for VK2809 and initiate a Phase 2b study in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) in 2H19.

  7. forum rang 10 DeZwarteRidder 18 augustus 2019 20:24
    Meanwhile, Genfit is also facing its own doubters. In mid-June, rival biotech company CymaBay Therapeutics (CBAY) offered a disappointing look at its PPAR drug in a Phase 2b study. In that study, reductions in liver fat remained minimal and insignificant compared with a placebo.
    "These data raise the risk for Genfit whose drug, elafibranor, is also a PPAR and we believe already had a low likelihood of success on NASH resolution in its upcoming year-end 2019 Phase 3 readout," RBC Capital Markets analyst Brian Abrahams said in a June report.
  9. forum rang 5 Hulskof 25 november 2019 14:15
    NEW YORK, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted Intercept’s New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) and granted priority review. The FDA grants priority review to drugs that have the potential to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

    “If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading cause of liver transplant in the U.S. as soon as 2020,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “It is exciting to achieve this critical regulatory milestone that brings us one step closer to our goal of delivering the first approved therapeutic to those living with this devastating disease. From OCA’s prior designation as a Breakthrough Therapy to the grant of priority review today, our work with FDA continues to set an important precedent for the field, and we look forward to working with the agency over the coming months as they review the first NDA in NASH.”

    The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 26, 2020 for the NDA. In the NDA filing acceptance notification letter, the FDA also indicated that it currently plans to hold an advisory committee meeting to discuss the application. A date for the advisory committee meeting has not been finalized and the timeline for the review of the NDA by the FDA remains subject to change.

    OCA is the only investigational therapy to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis. The NDA filing for OCA is supported by positive interim analysis results from the pivotal Phase 3 REGENERATE study in patients with liver fibrosis due to NASH. In the study, OCA 25 mg demonstrated robust improvement in liver fibrosis (by =1 stage) with no worsening of NASH at 18 months.
  12. forum rang 10 DeZwarteRidder 27 november 2019 20:00
    quote:

    Hulskof schreef op 27 november 2019 19:53:

    seekingalpha.com/article/4309489-pick...
    Summary

    I am looking to return to Viking Therapeutics for a long-term investment. I believe VK2809 has the potential to be one of the market's leading NASH products.

    I provide a brief background on VK2809 and the structure of the company's recently initiated Phase IIB trial. In addition, I discuss my view of VK2809.

    I discuss the stock's current market valuation and why investors should consider a speculative investment in VKTX.

    I am not new to Viking Therapeutics (VKTX) and its impressive endocrine pipeline. I originally invested in VKTX for its SARM product candidate VK5211. Admittedly, I wasn't aware of VK2809, the company's novel thyroid receptor beta agonist for NASH. Then again, I wasn't aware of the NASH craze that was going to be the talk of the biotech industry in 2018. Following VK2809's data readout, the stock soared over $20 per share and I was more than happy to hit my price target only a few months after establishing a position. Now that the NASH hype has subsided, I am looking for speculative NASH investment and it has led me back to VKTX.

    I will provide an overview of the recent developments related to VK2809. In addition, I take a look at VKTX's valuation to justify a speculative investment. Finally, I present my strategy for opening a starter position in VKTX.
  13. forum rang 10 DeZwarteRidder 27 november 2019 20:08
    2)
    Conclusion

    Viking Therapeutics recently initiated VK2809's VOYAGE study and is moving their flagship product candidate closer to the finish line. If successful, VK2809's results could reignite the stock and reinstall the momentum experienced back in 2018. Thus far, VK2809 has performed well in the clinic and I expect this one-of-a-kind NASH agent to be the front-runner on the market. Once those prospects have been confirmed, I anticipate an increase in attention from the market and a surge in acquisition chatter. I'm not going to invest due to speculation of whether or not Viking will be acquired, but I am more than happy to take advantage of the momentum and support generated by the assumption. As a result, I consider VKTX to be worthy of a speculative investment that could turn into a lucrative long-term investment.

    What's My Plan?

    Indeed, Viking won't record any product sales in the near future, but I believe the long-term estimated values permit an early speculative investment. Typically, I like to wait for a Phase III readout before clicking the buy button but I believe VK2809's data is strong enough to justify jumping in ahead of its pivotal study being completed. Unfortunately, I have overstretched my speculative healthcare investments, so I am going to have to wait to click the buy button. Once I have enough dry-powder, I will begin with a minuscule starter position and will add on technical pullbacks. I will have to maintain surveillance on other NASH product candidates and will anticipate potential spikes or sell-offs in response to their data readouts. My goal is to have a half-sized position before the end of 2020 and will hold that position through a pivotal study. Overall, I expect to hold VKTX for at least 5 years with a price target of $25.00 per share.
  16. galaking 26 maart 2024 21:50
    Viking boekt zeer goede resultaten in obesitas studies en de koers is dit jaar al sterk opgelopen. De markt voor medicijnen tegen obesitas is al groot en groeit naar verwachting in de komende jaren nog fors. Viking heeft ook nog andere medicijnen (NASH) in de pijplijn. Analisten hebben hoge verwachtingen voor Viking.
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