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☆ FDA approves Madrigal Pharmaceuticals drug as first treatment for common NASH liver disease
▼ + stars: | 2024-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

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

☆ Investors see a biotech comeback in 2024 as rates fall, deal-making picks up. Stocks to watch
▼ + stars: | 2023-12-28 | by ( Christina Cheddar Berk | In | ) www.cnbc.com time to read: +8 min

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

☆ Keep buying this GLP-1 juggernaut that's already up nearly 50% this year, TD Cowen says
▼ + stars: | 2023-12-04 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +2 min

Novo Nordisk is blessed with an extremely promising growth outlook, according to TD Cowen. NVO YTD mountain Novo Nordisk YTD chart Novo Nordisk is one of the largest makers of glucagon-like peptide 1 drugs used to treat both diabetes and obesity. "The company's merits have been widely recognized, and its shares have outperformed, but we believe there is more gas in the tank," the TD Cowen analyst wrote. For one, the analyst expects Novo's strong revenue and earnings growth to outpace its peers, especially as the company benefits from global GLP-1 supply constraints. "We are optimistic for favorable outcomes on all fronts," the analyst wrote.

Persons: TD Cowen, Michael Nedelcovych's, Cowen, Nedelcovych, Novo's, NASH, — CNBC's Michael Bloom Organizations: Novo Nordisk, Nordisk, Novo, European Union Locations: Danish, Novo

☆ Here are 5 anti-obesity drug stocks besides Novo Nordisk and Eli Lilly to watch into year-end
▼ + stars: | 2023-10-29 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +11 min

Novo Nordisk and Eli Lilly reign over the anti-obesity drug market, and don't expect this duopoly to end soon, analysts say. All this goes on amid robust demand for Novo's semaglutide, which is sold as Ozempic for type 2 diabetes and as Wegovy for weight loss, and Lilly's tirzepatide, which hopes to receive regulatory approval for weight loss this year. Orforglipron is an oral drug Eli Lilly is developing. It has several other compounds in the pipeline, but Suvannavejh expects the weight loss drug to receive increased attention. "This range would also be competitive with LLY's orforglipron [an oral GLP-1 drug] weight loss at day 28," Smith said.

Persons: Eli Lilly, Piper Sandler, Yasmeen Rahimi, Cantor Fitzgerald, Louise Chen, Lilly, Lilly's, Chen, Price, Kyle Rasbach, We've, Rasbach, Altimmune Altimmune, NASH, Piper's, Rahimi, Cantor's Chen, it's, Eli Lilly's Mounjaro, Goldman Sachs, Chris Shibutani, David Risinger, Risinger, Jonathan Wolleben, Wolleben, Orforglipron, Graig Suvannavejh, Suvannavejh, Thomas Smith, LLY's, Smith, Yale Jen, Jen Organizations: Novo Nordisk, Pfizer, Novo, pharma, Pfizer Pfizer, danuglipron, Therapeutics, Leerink, Mizuho Securities, Viking Therapeutics Viking Therapeutics, Laidlaw & Co Locations: Novo, GLP, Eventide

Electric vehicle companies Lucid , Fisker and Nikola have had a tough year — and Wall Street expects these stocks have even more downside potential. Nikola, which manufactures electric trucks, has seen its short interest jump nearly 14% to 157.7 million shares, or 27.3% of its float. More than a third of Arcutis Biotherapeutics 's free-float shares have been shorted by Wall Street, or 15.5 million shares. Liver disease treatment company Intercept Pharmaceuticals also saw a 12% jump in short interest, with 9.5 million shares sold short. Below is the full list of the most shorted stocks between July 31 and August 15.

Persons: Nikola, Fisker, Arcutis, scPharmaceuticals, Jerry Durso Organizations: EV, IGM Biosciences, Intercept Pharmaceuticals, U.S . Food, Drug Administration, NASH, Intercept, New York Stock Exchange Locations: FactSet, U.S

☆ Stocks making the biggest moves midday: RPT Realty, Mister Car Wash, Boston Scientific, 3M and more
▼ + stars: | 2023-08-28 | by ( Sarah Min | ) www.cnbc.com time to read: +3 min

RPT Realty — RPT Realty shares surged 17% after Kimco Realty, an operator of open-air shopping centers, said it would acquire the real estate investment trust in a roughly $2 billion all-stock deal. Mister Car Wash — The car wash stock advanced 6.1% on the back of an upgrade to overweight from neutral by Piper Sandler. Alibaba Group , JD.com — Alibaba and JD.com each added more than 2% after the Chinese government announced measures to boost its stock market, including reducing a tax on trading. Xpeng — Shares of the Chinese electric car company jumped 5.3% after the firm said it is buying Didi's smart electric car development business in an exchange of shares worth $744 million. Meanwhile, Xpeng said it plans to develop an electric car for launch next year under a new mass market brand.

Persons: Conor Flynn, Piper Sandler, — CrowdStrike, Morgan Stanley, —, Xpeng, Wells, Sarah Akers, Micron Technology — Stocks, — CNBC's Alexander Harring, Hakyung Kim, Yun Li, Jesse Pound, Pia Singh, Samantha Subin Organizations: RPT, Realty, Kimco Realty, Boston, Boston Scientific, Bloomberg, 3M, Akero Therapeutics, Therapeutics, UBS, Alibaba, Micron Technology —, Micron Technology, Marvell Technology, Semiconductors Locations: Xpeng

☆ Boehringer to test obesity drug in three late-stage trials
▼ + stars: | 2023-08-17 | by ( ) www.reuters.com time to read: +1 min

The logo of German pharmaceutical company Boehringer Ingelheim is seen at its building in Shanghai, China February 1, 2019. REUTERS/Stringer/File Photo Acquire Licensing RightsAug 17 (Reuters) - Germany's Boehringer Ingelheim said on Thursday it would conduct three late-stage studies for its obesity drug candidate after it showed up to 19% weight loss after 46 weeks in a mid-stage trial. The private company plans to start enrollments for the trial of the drug, survodutide, which it co-invented with Danish biotech company Zealand Pharma (ZELA.CO), before the end of the year. Boehringer and Zealand are among global drugmakers racing to grab a share of the potential $100 billion market for obesity treatments within a decade. Survodutide works by mimicing a gut hormone called glucagon-like peptide-1 (GLP-1), which suppresses appetite, as well as imitating another gut hormone called glucagon that helps break down fat.

Persons: Stringer, Boehringer Ingelheim, Boehringer, NASH, Leroy Leo, Sriraj Organizations: REUTERS, Zealand Pharma, Thomson Locations: Shanghai, China, Zealand, Bengaluru

☆ As weight loss drug stocks rallied on a landmark study, these stocks were over sold, analysts say
▼ + stars: | 2023-08-11 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +8 min

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

☆ Pfizer makes equity investment in Caribou Biosciences
▼ + stars: | 2023-07-06 | by ( ) www.reuters.com time to read: +2 min

July 6 (Reuters) - Pfizer (PFE.N) has invested $25 million to buy a minority stake in Caribou Biosciences (CRBU.O), making it the latest small biotechnology firm to attract the pharmaceutical giant's interest. The news lifted shares of Caribou more than 61% in early trade. Pfizer purchased nearly 4.7 million Caribou shares at $5.33 per share, Caribou said on Thursday, representing a premium of about 30% over Caribou's previous close price. This represents 7.64% of outstanding shares in Caribou, according to Reuters' calculation based on Refinitiv IBES data. It also made a $25 million equity investment in Akero Therapeutics (AKRO.O) last year.

Persons: Caribou, NASH, Jennifer Doudna, Raghav Mahobe, Leroy Leo, Maju Samuel Organizations: Pfizer, Caribou Biosciences, Biohaven Pharmaceutical, Akero Therapeutics, Thomson Locations: Caribou, California, Bengaluru

☆ US FDA staff flag 'serious' safety risks for Intercept's NASH treatment
▼ + stars: | 2023-05-17 | by ( ) www.reuters.com time to read: +2 min

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.

☆ Novo Nordisk rivals see room to compete in $100 billion weight-loss drug market
▼ + stars: | 2023-05-04 | by ( Michael Erman | ) www.reuters.com time to read: +6 min

The company has two oral GLP-1 drugs in mid-stage trials, and aims to choose one for a late-stage trial this year. He forecasts GLP-1s or similar drugs topping $100 billion in annual sales early in the 2030s, with Lilly's product accounting for more than $50 billion in sales. Smaller biotechs are also vying for a piece of the obesity market and hope large pharmaceutical companies will pay up for partnerships. "I don't know if it's $90 billion or $80 billion or $50 billion. The current GLP-1 drugs can cause nausea and vomiting.

☆ Drug developer 89Bio soars as NASH drug succeeds in mid-stage study
▼ + stars: | 2023-03-22 | by ( ) www.reuters.com time to read: +2 min

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.

☆ Surprising Fatty Liver Results Could Put Madrigal in Big Pharma’s Sights
▼ + stars: | 2022-12-19 | by ( David Wainer | ) www.wsj.com time to read: 1 min

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.

☆ Madrigal NASH drug meets goals in much-awaited trial, shares surge
▼ + stars: | 2022-12-19 | by ( ) www.reuters.com time to read: +1 min

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.

☆ A tiny biotech's experimental treatment for a silent disease that strikes millions just cleared a key hurdle and the stock is up more than 200%
▼ + stars: | 2022-12-19 | by ( Sarah Braner | ) www.businessinsider.com time to read: +2 min

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.

☆ A Chronic Disease Still Waiting for a Drug
▼ + stars: | 2022-09-20 | by ( David Wainer | ) www.wsj.com time to read: +1 min

Drug companies have developed treatments for some of the rarest diseases afflicting a tiny percentage of the population, yet they have failed repeatedly to get a drug on the market for a chronic and increasingly common one. As biotech companies take new shots on goal for the liver disease known as NASH, or nonalcoholic steatohepatitis, investors are understandably reluctant after being burned repeatedly. Take Intercept Pharmaceuticals which at the height of the Wall Street excitement over NASH treatments fetched as much as $462 a share. The stock has since plunged, trading now at just over $17, erasing $6 billion in market value. The biotech’s drug for NASH was rejected by the U.S. Food and Drug Administration in 2020 because of safety concerns, but Intercept is trying again.

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