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In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailMadrigal Pharma CEO talks competition in the GLP-1 space and new drug rolloutsBill Sibold, Madrigal Pharma CEO, joins 'Fast Money' to talk GLP-1 drug competition, its liver disease treatment, its Mash drug rollout and more.
Persons: Bill Sibold Organizations: Madrigal, Madrigal Pharma
Hedge funds and other short sellers are betting against plenty of stocks even as the market sets new record highs. Many short sellers have pulled back since the start of the meme stock craze, but the practice of betting against stocks is still around. But with interest rates falling and stocks broadly climbing this week, those targeted stocks could be candidates for a so-called short squeeze. In certain cases, this can create a feedback loop where the extra buying pressure forces other short sellers to do the same. That performance could make them more likely to have a short squeeze in the near term, though the exact financial position of those short sellers is unknown.
Persons: Citron Research, Nick Wells Organizations: Arbor Realty Trust, Medical Properties Trust, Federal Reserve, Comstock Resources, Madrigal Pharmaceuticals, GameStop Locations: Arbor, U.S
With the Fed, Apple earnings and the jobs report passing with flying colors this week, the runway to more gains looks a lot less cluttered. This past week was chock full of Club earnings: 12 portfolio companies, including Apple , delivered results. Analysts expect Wynn's earnings per share of $1.27 versus 29 cents a year ago when China was not fully back from Covid. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio.
Persons: Jerome Powell, we're, Jim Cramer, Jim, Apple, Eli Lilly, Estee Lauder, Stanley Black, Decker, Bausch, FactSet, It's, Bob Iger, Iger, Nelson Peltz, We're, Krystal, Berkshire Hathaway, Tyson, Jones Lang, Walt, Ferrari N.V, WK Kellogg, Wynn, Vishay, CRON, MARA, RICK, Ginkgo, Jim Cramer's, David Paul Morris Organizations: Federal Reserve, Apple, GE Healthcare, DuPont, Linde, Bausch Health, Coterra Energy, Club, Disney, Wynn Resorts, CNBC, Revenue, Vegas Sands, Cotai, Boston, Airlines, Krystal Biotech, Alpha Metallurgical Resources, Axsome Therapeutics, Tyson Foods, TSN, Bowlero Corp, CNA Financial Corp, CNA, Jones Lang LaSalle Incorporated, Technologies, Realty Income Corp, Lab, Teradata Corp, Technology, FMC Corporation, FMC, Paymentus Holdings, Shockwave, Vertex Pharmaceuticals, Goodyear Tire & Rubber Company, Simon Property Group, Sterling Construction Company, Apple Hospitality, Boise Cascade Corporation, BellRing Brands, Coty, COTY, Fidelity National Information Services Inc, Vornado Realty, Walt Disney Co, Holdings, Madrigal Pharmaceuticals, Nikola Corporation, BP, Rockwell Automation, MarketAxess Holdings, Jumia Technologies, GEO Group, Builders FirstSource Inc, Duke Energy Corp, WYNN, Rivian Automotive, Arista Networks, Occidental Petroleum Corp, Astera Labs, Bros, Flywire Corporation, B2Gold Corp, Kinross Gold Corp, Virgin Galactic Holdings, iRobot Corp, Electronic Arts Inc, McKesson Corp, ACM Research, Avadel Pharmaceuticals, Toyota Motor Corp, Emerson Electric Co, Perion, Editas, Brink's Company, Sinclair Corporation, New Fortress Energy, Starwood Property Trust, Animal Health, ELAN, Farms, IM Cannabis Corp, Fox Corporation, Formula One, Icahn Enterprises, Teva Pharmaceutical Industries, Arm Holdings plc, ARM, AMC Entertainment Holdings, Trade, AppLovin Corporation, Sciences Corp, SolarEdge Technologies, Roblox Corporation, GigaCloud Technology Inc, Warner Bros ., Properties Trust, Growers, Constellation Energy Group, Cronos, Fiverr, Solar Inc, EPAM Systems, Cedar Fair Entertainment, Digital Holdings, RCI Hospitality Holdings, Akamai Technologies, Semiconductor, Insulet Corp, NuScale Power Corporation, Ginkgo Bioworks Holdings, Bloom Energy Corporation, Construction, AMC Networks, CRH Public Ltd . Company, Jim Cramer's Charitable, Allen, Co . Media, Technology Conference, Bloomberg, Getty Locations: China, Eaton, Amazon, Covid, Macao, Vegas, Sun Valley , Idaho
The Food and Drug Administration on Thursday approved the first-ever treatment for a common and potentially deadly form of liver disease that affects millions worldwide. Novo Nordisk and Eli Lilly are testing their respective blockbuster weight loss injections as treatments for the same kind of liver disease, called nonalcoholic steatohepatitis, or NASH. Madrigal's drug, which will be marketed as Rezdiffra, is specifically approved to treat patients with NASH who also have moderate-to-advanced liver scarring. NASH is a serious form of liver disease characterized by excess fat buildup and inflammation in the liver and can lead to liver scarring, also known as fibrosis, along with liver failure and liver cancer. Roughly 6 million to 8 million people in the U.S. have NASH with moderate-to-advanced liver scarring, according to an estimate cited by the FDA.
Persons: Madrigal, Eli Lilly, NASH, Nikolay Nikolov, Rezdiffra Organizations: Madrigal Pharmaceuticals, Drug Administration, Pharmaceuticals, Novo Nordisk, FDA, Immunology Locations: U.S
Here are Wednesday's biggest calls on Wall Street: Berenberg upgrades Honeywell to buy from hold Berenberg said the industrial conglomerate is well positioned. Roth MKM initiates Aspen Aerogels as buy Roth said it sees a "strong secular opportunity" for the insulation company. HSBC upgrades Target to buy from neutral HSBC said it likes the company's strategy following earnings on Tuesday. " Target's strategy aims to drive long-term sales growth market share gains and improve profitability Deutsche Bank upgrades Target to buy from neutral Deutsche upgraded Target following earnings on Tuesday. Argus initiates Super Micro as buy Argus said it sees "years" of growth for shares of Super Micro.
Persons: Berenberg, Morgan Stanley, Tesla, Roth MKM, Roth, JPMorgan, Wolfe, Evercore, Needham, SMCI Organizations: Honeywell, Barclays, Aspen, HSBC, Target, Deutsche Bank, Deutsche, JPMorgan, BBB, Citi, Madrigal Pharmaceuticals, Motors, RBC, EV, ISI, Bank of America, Google, Apple, Nvidia, NVIDIA, Crinetics Pharmaceuticals, Argus, Super Locations: China, Dominion
Many biotech stocks struggled in 2023 despite a robust year for U.S. drug approvals. "We expect this environment to continue but look forward to the prospect of lower interest rates in 2024." When that happens, Canaccord Genuity said to expect a "strong rally across the biotech sector rewarding innovative, but riskier assets." Analysts have said the rich price reflects the opportunity for ImmunoGen's Elahere cancer treatment , which has quickly established itself as the standard of care for types of ovarian cancer. 'Oversold and cheap' In a research note Friday, Jefferies analyst Michael Yee said "a significant short squeeze" was helping biotech stocks in the fourth quarter.
Persons: Dan Lyons, Janus Henderson, John Newman, Canaccord Genuity, Janus, Lyons, Bristol Myers Squibb, Karuna, AstraZeneca, Eli Lilly, AbbVie, Jonathan Miller, Miller, bode, Jonathan Krinsky, Krinsky, BTIG's, Jefferies, Michael Yee, Yee, NASH, Madrigal, we're, David Risinger, — CNBC's Michael Bloom Organizations: Drug, Federal, Bristol Myers, Karuna Therapeutics, CART, Bristol Myers Squibb, Cerevel Therapeutics, Securities and Exchange Commission, pharma, P Biotech, Nasdaq Biotech, Apogee Therapeutics, Madrigal Pharmaceuticals, Madrigal, resmetirom, Vertex Pharmaceuticals, Leerink Partners Locations: ImmunoGen
However, the pharmaceutical companies are making the case that weight loss can improve health, and possibly lower health-care costs over time. But analysts have said the news isn't all bad for such stocks, and many were fell too low on Tuesday. Deutsche Bank analyst Imron Zafar estimated Thursday that bariatric surgery accounts for about 5% of Intuitive Surgical's U.S. robotic surgery business, but has been driving much of the company's growth. Some of the surgeons Zafar spoke with said any drop off in bariatric surgery was likely to be offset by increased use of the robot for other procedures. But they expect the drugs will remain necessary because GLP-1 drugs have yet to show they improve fibrosis, which is associated with NASH.
Persons: nonalcoholic steatohepatitis, NASH, Abbott, Robbie Marcus, Marcus, Marcus doesn't, Goldman Sachs, Goldman, Stryker, Smith, Zimmer Biomet, Bariatric, Imron Zafar, Zafar Organizations: Novo Nordisk, Abbott Laboratories, CNBC, JPMorgan, Companies, Inspire Medical Systems, Resmed, Philips, Nephew, Deutsche Bank, Madrigal Pharmaceuticals, Sagimet Biosciences, Akero Therapeutics, Terns Pharmaceuticals, Viking Therapeutics, Madrigal Locations: U.S
Novartis buyback offers partial cure for M&A risk
  + stars: | 2023-07-18 | by ( ) www.reuters.com   time to read: +2 min
LONDON, July 18 (Reuters Breakingviews) - Novartis’s (NOVN.S) bumper buyback will offer a little relief to investors. Many had been waiting to see what the $225 billion Swiss pharma giant would do with an extra $20 billion burning a hole in its pocket after Roche(ROG.S) bought back its stake in 2021. It needs new drugs to replenish its pipeline and boost an ailing share price, which has still not recovered since the pandemic. But on Tuesday, CEO Vasant Narasimhan said he will launch a $15 billion buyback programme. The Swiss drugmaker’s $15.4 billion of net debt is less than 1 times its forecast 2023 EBITDA, according to Refinitiv.
Persons: Roche, Vasant Narasimhan, can’t, Aimee Donnellan, Xavier Niel’s, Neil Unmack, Streisand Neto Organizations: Reuters, Swiss pharma, Alcon, Madrigal Pharmaceuticals, Novartis, Twitter, Xavier Niel’s GAM, Commonwealth Games, Thomson Locations: Swiss
The U.S. Food and Drug Administration's (FDA) briefing document highlighted increased risk of diabetes and liver injury from using the obeticholic acid (OCA) oral tablets for the treatment of nonalcoholic steatohepatitis (NASH). "During the course of our review, FDA identified modest benefits and serious risks of OCA for treatment of NASH," the staff said in the document and listed increased risk of sludge formation in the gall bladder and imbalance of certain lipids. The staff asked the regulator's panel of outside advisors, who are meeting on Friday, to consider whether the modest benefits from using the drugs for NASH treatment outweigh the serious risks associated with it. The panel's meeting on Friday is the first such meeting for a NASH treatment. However, due to risks of serious liver injury, FDA restricted its usage in 2021 to primary biliary cholangitis patients with advanced cirrhosis, or severe liver scarring.
March 22 (Reuters) - Drug developer 89Bio Inc <ETNB.O> said on Wednesday its experimental treatment for liver disease NASH met the main goals of a small mid-stage study, sending its shares 30% higher. The drug, pegozafermin, helped reduce liver scarring known as fibrosis as measured on two different scales in patients with NASH, or nonalcoholic steatohepatitis, trial data showed. 89Bio said the drug, administered both weekly and every two weeks in the trial, had a safety profile similar to older trials. In the trial, the drug helped significantly reduce fibrosis or liver scarring without the worsening of NASH, compared to a placebo. NASH, a form of non-alcoholic fatty liver disease, is characterized by the organ developing fibrosis or scarring, which can progress to cirrhosis and liver failure.
Baker Bros. Advisors, a secretive hedge fund that counts Yale University's endowment and the Tisch family as its clients, held onto a slew of its favorite biotech names last quarter. Its portfolio has grown to be the 15th-biggest among U.S. hedge funds through 2022, according to FactSet, despite its lack of notoriety. The hedge fund specializes in biotech investing as the founders, now in their 50s, take advantage of their educational background in immunology, riding on the explosive growth in the sector over the past decade. Meanwhile, Yale's charitable foundation has invested in 667 LP — a Baker Bros. vehicle — since at least 2009. The hedge fund slightly increased its exposure to Madrigal Pharmaceuticals and Rhythm Pharmaceuticals last quarter, the filing showed.
But even with the huge win in 2022, short sellers still lag in recent history. Shorted stocks had a return of 30.8% in 2022, said Ihor Dusaniwsky, the firm's managing director of predictive analytics. That means short sellers outperformed the broader market, which suffered its biggest losses since 2008. When an investor sells a stock "short" they borrow shares from a broker and sell them in hopes of buying the stock back later at a lower price. Short sellers still needed to be good stock pickers in 2022 as different sectors and individual holdings could produce vastly different results, Dusaniwsky said.
Stocks may be careening toward their worst year since 2008, but some names are completing a remarkable run after doubling or more in 2022. In 2022, the Dow Jones Industrial Average has lost 8.4%, while the S & P 500 shed 19.2%. These stocks are up more than 100% this year, and include tankers for petroleum products, energy companies such as coal firms, and biotech and pharmaceutical names, according to CNBC. Ardmore Shipping and Scorpio Tankers were the top tanker stocks, both up about 316% for the year. Energy companies came out on top in 2022 following a surge in oil and gas prices — which market participants say will remain elevated given expectations of tight supply ahead.
There have been so many disappointing trial results targeting the liver disease known as NASH, or nonalcoholic steatohepatitis, that investors were understandably cautious going into one small biotech’s late-stage results. Yet the topline results released by Madrigal Pharmaceuticals on Monday looked better than most analysts had expected, sending the stock soaring 220%. Ahead of the results, most analysts expected the study to achieve one of the two primary endpoints—a reduction in inflammation—but weren’t as confident it could also deliver on the reduction of liver scarring. The latter is an important measure because it can lead to complications such as cirrhosis.
Dec 19 (Reuters) - Madrigal Pharmaceuticals' (MDGL.O) experimental drug for fatty liver disease met both of the main goals in a highly anticipated late-stage study, it said on Monday, sending the company's shares soaring over 200%. The positive data sets the stage for the drug, resmetirom, to become the first approved treatment for NASH, or nonalcoholic steatohepatitis, a disease that affects about 5% of adults in the United States. Data from the trial shows a lower 80 milligram dose helped 26% of patients reach NASH resolution, compared to 30% for a higher 100 milligram dose, and 10% for placebo. NASH is a form of nonalcoholic fatty liver disease, characterized by the organ developing fibrosis or scarring, which can progress to cirrhosis and liver failure. The company plans to file a marketing application seeking accelerated approval for the drug in the first half of 2023.
Madrigal Pharmaceuticals reported positive results in its phase 3 trial for a drug to treat NASH. NASH is a serious liver condition that does not have an FDA-approved treatment. Many people don't even know they have it, which is why some people call it a "silent" disease. In a trial of more than 950 patients, 26% of patients taking 80mg and 30% of patients taking 100mg of the drug showed that NASH activity like swelling had been reduced. Pharma hasn't found a way to treat NASH yetThe pharma industry has been watching NASH for a while.
Options Action: Action in MDGL
  + stars: | 2022-12-19 | by ( ) www.cnbc.com   time to read: 1 min
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailOptions Action: Action in MDGLOptimize Advisors' Mike Khouw looks at the action in Madrigal Pharmaceuticals on Friday ahead of a big clinical trial. With CNBC's Melissa Lee and the Fast Money traders, Chris Verrone, Karen Finerman, Steve Grasso and Julie Biel.
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