crudeoil24
2 years ago
MDGL > 52-week serial liver biopsy Phase 3 study in more than 950 patients, resmetirom achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses, 80 mg and 100 mg, relative to placebo
NASH resolution (ballooning of 0, inflammation of 0-1) and greater-than or equal to2-point NAS reduction with no worsening of fibrosis (p<0.0001 at both doses)
Fibrosis improvement by at least one stage with no worsening of NAS (p=0.0002 and <0.0001 at 80 and 100 mg, respectively)
Potentially clinically meaningful LDL-lowering, a key secondary endpoint (p<0.0001)
Multiple positive effects on NASH biomarkers and imaging
Resmetirom was safe and well-tolerated in the MAESTRO-NASH study, consistent with the overall safety in Phase 3 MAESTRO trials, expanding the large safety database
Madrigal intends to file a new drug application seeking accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis
DMOST
6 years ago
Better Buy: Intercept Pharmaceuticals vs. Madrigal Pharmaceuticals
Around 20 million Americans have a progressive, life-threatening liver condition called non-alcoholic steatohepatitis (NASH), and there's isn't much doctors can do about it besides recommending fewer calories and more exercise.
Any day now, Intercept Pharmaceuticals (NASDAQ: ICPT) will share long-awaited pivotal trial results that could make its Ocaliva drug the first approved NASH treatment. The lead candidate at Madrigal Pharmaceuticals (NASDAQ: MDGL) is behind Ocaliva on the development timeline, but results so far tick all the right boxes. Let's examine the case for both stocks to decide which one is the better pick right now.
Two men in business attire are wearing boxing gloves. One has his head lowered, while the other has his arms raised in celebration.
Investigators are going to present long-awaited interim results for Intercept's only drug, Ocaliva in the first quarter. It's been five long years since midstage results sent the stock rocketing higher. A surprising 45% of patients given Ocaliva for 72 weeks showed significant NASH improvements, compared with just 21% of the placebo group.
Defining NASH is still a work in progress, but it involves liver cells that retain more lipids than they should, which causes them to balloon and become too inflamed to function properly. Since the condition progresses slowly, the FDA is willing to grant accelerated approval to the first candidate that can reduce NASH symptoms or reduce the scarring caused by long-term inflammation. Ocaliva hit both marks in its midstage study, and a repeat performance could send the stock soaring again.
The FDA approved Ocaliva in 2016 for the treatment of primary biliary cholangitis (PBC), a condition in which the immune system damages the path bile takes from liver to the stomach. Bile acids that back up into liver tissue cause all sorts of problems for an estimated 130,000 Americans with PBC, and this population needed a new treatment option.
Ocaliva is a super-potent analog of a natural bile acid, but PBC patients with seriously impaired livers should start with just 5 mg per week. More than a few patients with severe cirrhosis died after taking the recommended dosage for healthier patients, which is 5 mg every day. A more stringent risk mitigation strategy is doing its job, and sales are climbing again.
During the first nine months of 2018, Ocaliva sales rose 36% over the previous-year period to $125 million. That will help extend the company's cash runway, but not by much. Intercept's operating expenses reached $330 million during the same period.
At the end of September, the company had $489 million in cash after losing $221 million during the first nine months of 2018. If Intercept's long-awaited NASH results disappoint, raising any more cash will become nearly impossible. Beyond Ocaliva, the company doesn't have anything coming through its pipeline.
Benjamin Franklin hiding under some tablets.
This pre-commercial biotech is developing a tablet that acts on the thyroid hormone receptor beta (TRB), which seems like the right target for treating NASH. Biopsies taken during a midstage study with MGL-3196 showed that 56% of patients given the drug experienced a significant reduction of NASH symptoms after 36 weeks, compared with just 32% of the placebo group.
Madrigal's experimental treatment ticked another box by reducing fibrosis as well. If MGL-3196 can produce improvements to NASH and the fibrosis it causes in a pivotal study as well, the drug should clear the FDA's hurdles without any trouble.
Although the agency is primarily concerned with inflammation and scarring, MGL-3196 impressed investors by helping NASH patients lower liver fat content, measured with an MRI, by 37%, compared with a 9% reduction in the placebo group. Shortly after Madrigal's day in the sun, though, Viking Therapeutics (NASDAQ: VKTX) released data for its TRB agonist that showed a liver fat reduction that was much stronger, but we haven't seen any biopsy results from a Viking candidate yet.
Madrigal doesn't have a revenue stream yet, but the clinical-stage biotech is running a much smaller operation than Intercept. In fact, Madrigal licensed its only clinical-stage candidate from Roche (NASDAQOTH: RHHBY) and owes the pharma giant a single-digit royalty percentage if MGL-3196 hits pharmacy shelves. Despite a complete lack of revenue during the first nine months of 2018, Madrigal lost just $21 million during the first nine months of 2018.
Phase 2 results for MGL-3196 hit the mark last May, but Madrigal still hasn't told investors if its phase 3 study for MGL-3196 will begin before the end of 2019. Madrigal finished September with $489 million in cash, which means it can probably afford to wait for a deep-pocketed drugmaker to make a buyout offer, or at least a partnership deal.
The better buy
If trial results on the way this quarter fall in line with earlier observations, Intercept could have a gigantic addressable patient population all to itself. The NASH market probably won't stay sewn up for long. A large underserved patient population has inspired a great deal of drug development, and right now there are dozens of potential competitors in mid- to late-stage testing.
Madrigal's $2.1 billion market cap seems like a compelling bargain for a drugmaker that wants to jump into NASH with a drug ready for late-stage testing, but we'll probably have to wait until at least one proves itself in the commercial setting. Intercept's a little more expensive than Madrigal, with a recent market cap of $3.2 billion, but Ocaliva's revenue stream now, coupled with a great chance at becoming the NASH population's first treatment option, makes it the better buy at the moment.
GO MDGL
"PEACE"
DMOST
6 years ago
Here is What Hedge Funds Think About Madrigal Pharmaceuticals, Inc. (MDGL)
Abigail Fisher
,Insider Monkey•December 13, 2018
Looking for stocks with high upside potential? Just follow the big players within the hedge fund industry. Why should you do so? Let’s take a brief look at what statistics have to say about hedge funds’ stock picking abilities to illustrate. The Standard and Poor’s 500 Index returned approximately 5.7% in the 12 months ending October 26 (including dividend payments). Conversely, hedge funds’ 30 preferred S&P 500 stocks (as of June 2014) generated a return of 15.1% during the same 12-month period, with 53% of these stock picks outperforming the broader market benchmark. Coincidence? It might happen to be so, but it is unlikely. Our research covering the last 18 years indicates that hedge funds' stock picks generate superior risk-adjusted returns. That's why we believe it is wise to check hedge fund activity before you invest your time or your savings on a stock like Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL).
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) was in 26 hedge funds' portfolios at the end of September. MDGL has seen an increase in support from the world's most elite money managers of late. There were 21 hedge funds in our database with MDGL holdings at the end of the previous quarter. Our calculations also showed that MDGL isn't among the 30 most popular stocks among hedge funds.
So, why do we pay attention to hedge fund sentiment before making any investment decisions? Our research has shown that hedge funds' small-cap stock picks managed to beat the market by double digits annually between 1999 and 2016, but the margin of outperformance has been declining in recent years. Nevertheless, we were still able to identify in advance a select group of hedge fund holdings that outperformed the market by 18 percentage points since May 2014 through December 3, 2018 (see the details here). We were also able to identify in advance a select group of hedge fund holdings that underperformed the market by 10 percentage points annually between 2006 and 2017. Interestingly the margin of underperformance of these stocks has been increasing in recent years. Investors who are long the market and short these stocks would have returned more than 27% annually between 2015 and 2017. We have been tracking and sharing the list of these stocks since February 2017 in our quarterly newsletter. Even if you aren't comfortable with shorting stocks, you should at least avoid initiating long positions in our short portfolio.
Felix Baker - Baker Bros.
Felix Baker - Baker Bros.
Let's take a peek at the key hedge fund action regarding Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL).
What does the smart money think about Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL)?
At Q3's end, a total of 26 of the hedge funds tracked by Insider Monkey held long positions in this stock, a change of 24% from one quarter earlier. Below, you can check out the change in hedge fund sentiment towards MDGL over the last 13 quarters. So, let's see which hedge funds were among the top holders of the stock and which hedge funds were making big moves.
MDGL_dec2018
MDGL_dec2018
The largest stake in Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) was held by Baker Bros. Advisors, which reported holding $250.4 million worth of stock at the end of September. It was followed by venBio Select Advisor with a $99.1 million position. Other investors bullish on the company included Rock Springs Capital Management, Healthcor Management LP, and Point72 Asset Management.
Now, specific money managers were breaking ground themselves. Point72 Asset Management, managed by Steve Cohen, established the most valuable position in Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL). Point72 Asset Management had $20.3 million invested in the company at the end of the quarter. Steven Boyd's Armistice Capital also initiated a $17.1 million position during the quarter. The following funds were also among the new MDGL investors: Jeffrey Jay and David Kroin's Great Point Partners, Principal Global Investors's Columbus Circle Investors, and Paul Marshall and Ian Wace's Marshall Wace LLP.
Let's now take a look at hedge fund activity in other stocks - not necessarily in the same industry as Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) but similarly valued. We will take a look at Ellie Mae Inc (NYSE:ELLI), Guangshen Railway Co. Ltd (NYSE:GSH), ACI Worldwide Inc (NASDAQ:ACIW), and GATX Corporation (NYSE:GATX). This group of stocks' market valuations match MDGL's market valuation.
[table] Ticker, No of HFs with positions, Total Value of HF Positions (x1000), Change in HF Position ELLI,15,613258,2 GSH,1,4749,0 ACIW,15,298192,-2 GATX,11,267813,1 Average,10.5,296003,0.25 [/table]
View table here if you experience formatting issues.
As you can see these stocks had an average of 10.5 hedge funds with bullish positions and the average amount invested in these stocks was $296 million. That figure was $576 million in MDGL's case. Ellie Mae Inc (NYSE:ELLI) is the most popular stock in this table. On the other hand Guangshen Railway Co. Ltd (NYSE:GSH) is the least popular one with only 1 bullish hedge fund positions. Compared to these stocks Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) is more popular among hedge funds. Considering that hedge funds are fond of this stock in relation to its market cap peers, it may be a good idea to analyze it in detail and potentially include it in your portfolio.
https://finance.yahoo.com/news/hedge-funds-think-madrigal-pharmaceuticals-040346370.html
GO MDGL
"PEACE"
DMOST
6 years ago
Here's Why Madrigal Pharmaceuticals Fell 39.4% in November
What happened
Shares of Madrigal Pharmaceuticals (NASDAQ: MDGL), a clinical-stage biotechnology company, fell 39.4% in November, according to data from S&P Global Market Intelligence. Madrigal presented impressive clinical trial results for its lead candidate that were overshadowed by a surprise from a potential rival.
So what
Non-alcoholic steatohepatitis (NASH) is a growing epidemic that threatens the lives of an estimated 20 million Americans at the moment, and there aren't available treatments proven to help. There's an even larger population of people with non-alcoholic fatty liver disease (NAFLD), a condition that progresses to NASH once the liver becomes inflamed and begins sustaining damage.
Nobody's quite sure what causes the immune system to begin attacking fatty livers, but reducing their overall fat content seems like a step in the right direction. Madrigal's lead candidate, MGL-3196, is a potential first-in-class treatment called a thyroid hormone receptor-beta (TRB) agonist. Trial results presented at a medical conference in November showed MGL-3196 led to a 37% average liver fat reduction for NASH patients after 36 weeks of treatment.
Unfortunately for Madrigal, Viking Therapeutics (NASDAQ: VKTX) presented results from a midstage trial with another experimental TRB agonist that's a little further back on the development timeline. Treatment with VK2809 helped NAFLD patients reduce their liver fat content by 59%, which appears to wipe the floor with results from MGL-3196.
Now what
Investors should bear in mind that the varied results don't necessarily mean one treatment is any better than the other, because they were tested different groups of patients. Viking's midstage study enrolled NAFLD patients who haven't progressed to NASH. Until we see results from a head-to-head trial or at least similar patient groups, any comparisons between VK2809 and MDGL-3196 need to be taken with a huge grain of salt.
Madrigal shareholders who have held on despite recent losses can take heart in the FDA's recent draft guidance regarding NASH drug development. The disease progresses too slowly to measure survival outcomes, so the agency's willing to consider new NASH treatments for approval if they reverse or at least control symptoms of inflammation and stiffening of liver tissue. Patients treated with MDGL-3196 were 450% more likely to experience resolution of their NASH symptoms than those given a placebo. Another performance like this in a pivotal study would almost meet the agency's criteria.
https://finance.yahoo.com/news/apos-why-madrigal-pharmaceuticals-fell-200300888.html
GO MDGL
"PEACE"
DMOST
6 years ago
MDGL has now lost all the gains from the big bounce to $326...........Such be the way of the markets.
Meanwhile..........
Madrigal Pharmaceuticals Inc (MDGL) CEO Paul A Friedman Bought $496,000 of Shares
[GuruFocus.com]
GuruFocus.com
,GuruFocus.com•November 20, 2018
- By insider
CEO of Madrigal Pharmaceuticals Inc (MDGL) Paul A Friedman bought 4,000 shares of MDGL on 11/19/2018 at an average price of $124 a share. The total cost of this purchase was $496,000.
Madrigal Pharmaceuticals Inc is a company focused on the development of novel compounds for the treatment of cardiovascular-metabolic diseases and nonalcoholic steatohepatitis (NASH). Madrigal Pharmaceuticals Inc has a market cap of $1.85 billion; its shares were traded at around $120.50 . Madrigal Pharmaceuticals Inc had annual average EBITDA growth of 43.80% over the past five years.
Warning! GuruFocus has detected 5 Warning Signs with WBA. Click here to check it out.
MDGL 15-Year Financial Data
The intrinsic value of MDGL
Peter Lynch Chart of MDGL
CEO Recent Trades:
CEO Paul A Friedman bought 4,000 shares of MDGL stock on 11/19/2018 at the average price of $124. The price of the stock has decreased by 2.82% since.
Directors and Officers Recent Trades:
Director, 10% Owner Fred B Craves bought 2,000 shares of MDGL stock on 11/19/2018 at the average price of $124.69. The price of the stock has decreased by 3.36% since.
GO MDGL
"PEACE"
DMOST
6 years ago
Is Viking Therapeutics the Best NASH Stock to Buy Now?
Shares of Viking Therapeutics (NASDAQ: VKTX) soared after the biotech announced solid results for its lead candidate. That's because it's aimed at treating non-alcoholic steatohepatitis (NASH), or liver damage caused by excess fat buildup. NASH threatens the lives of around 20 million Americans, and there aren't any effective treatment options yet.
Viking Therapeutics probably won't be the first biotech to market a NASH treatment, but it looks like its lead candidate could be best at stopping NASH from occurring in the first place. Let's look at what results for VK2809 could mean for Viking shareholders down the road to see if this is the best NASH stock investors can buy right now.
Viking recently showed investors that 10 mg of VK2809 taken daily lowered the fat content of livers in patients with non-alcoholic fatty liver disease (NAFLD), which is a precursor to NASH. After 12 weeks of treatment with 10 mg of VK2809 daily, a majority of patients achieved liver fat reductions of 59.7%, compared to just 8.9% for those given a placebo. Investigators also reported that 90.9% of those treated daily achieved a 30% reduction or better versus just 18.2% of those given a placebo.
Viking's potential new NASH drug works in the same way as a candidate from Madrigal Pharmaceuticals (NASDAQ: MDGL) called MGL-3196. In late 2017, Madrigal stock shot up when the company announced a 36.3% liver fat reduction for patients treated with an 80 mg starting dose of MGL-3196 that was adjusted up or down according to patients' ability to tolerate it. Madrigal's drug helped 60.3% of patients who took it to achieve a 30% or better liver fat reduction, versus just 18.4% of those in the placebo group.
Although it looks like Viking just wiped the floor with the competition, investors should know that Madrigal only enrolled patients that had biopsy-proven NASH, while Viking didn't require any signs of liver damage, just the same 10% minimum liver fat content as Madrigal's trial. Until we see these drugs go head to head, or at least enroll similar patients, we really can't claim victory for either one.
Between 30% and 40% of U.S. adults have NAFLD, which develops into NASH perhaps 20% of the time. Most patients don't notice NASH or know what the problem is until the inflammation has already damaged their livers.
Few Americans are familiar with NASH, but it's already the leading cause of liver transplants among U.S. women. That means demand should be strong enough for VK2809 plus a competitor or two to generate blockbuster sales.
Neither Madrigal or Viking is ready to start pivotal studies with their NASH candidates, which means there's a good chance neither will launch the first available treatment. Luckily, VK2809 sailed through phase 2 without causing any serious adverse events.
Ocaliva, from Intercept Pharmaceuticals (NASDAQ: ICPT) will probably be the first NASH treatment to earn an FDA approval, but safety concerns so far mean it will remain limited to those in advanced stages of the disease. Results from an ongoing phase 3 trial will be ready next year, but they're intended to support an expansion to treat severe NASH patients with fibrosis already.
Beyond NASH
Viking Therapeutics has another candidate in late-stage testing that could be a big winner as well. VK5211 is supposed to deliver the benefits that testosterone provides to muscle and bone without the unwanted side effects.
Earlier this year, Viking showed us that patients given VK5211 while recovering from hip fractures showed significant increases in lean body mass. Around 300,000 Americans break a hip each year, and VK5211 could become the first drug specifically approved to help older adults improve bone density in a way that gives them a better chance of walking again.
Viking hasn't laid out plans for a pivotal study even though a meeting with the FDA to discuss a path forward was scheduled for the third quarter. Viking wants a deep-pocketed partner to pay for VK5211's late-stage clinical development expenses in return for milestone payments and royalties on sales if it succeeds.
Although VK5211 leads to statistically significant improvements to patients' lean body mass, so does testosterone. Every week that goes by without news of a partnership for the potential blockbuster raises the fear that drugmakers don't think insurers will pay for an expensive new drug to avoid the side effects of traditional androgen therapy.
Finding a partner for VK5211 or VK2809 will be a bit more challenging than usual because Viking doesn't own the drugs outright. Viking licensed them from Ligand Pharmaceuticals (NASDAQ: LGND) a few years ago and owes Ligand single-digit royalties on any sales either drug might generate. Coincidentally, Madrigal entered a similar agreement with Roche to get its hands on MGL-3196 back in 2008.
The best NASH stock?
At recent prices, Viking Therapeutics boasts a $1.3 billion market cap that could rise much further if VK2809 or VK5211 attracts a deep-pocketed partner in the near term. If the industry's larger players choose to remain disinterested, though, things could get awfully dicey.
I'd say that Viking Therapeutics is a good stock for investors who want to invest in the growing NASH space, but I'm not going to place it ahead of Intercept or Madrigal yet. If a bigger drugmaker with the means to develop and launch one of Viking's drugs comes to the deal table, though, it could quickly rise to the top.
https://finance.yahoo.com/news/viking-therapeutics-best-nash-stock-124800775.html
GO MDGL
"PEACE"
News, positive or negative, trumps all.............
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