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Akero Therapeutics could be a winner in the race to treat non-alcoholic steatohepatitis, a potentially life-threatening liver disease. Nash is a severe form of fatty liver disease which can cause inflammation of the liver and fibrosis, or scarring, of the liver. The disease can also lead to cirrhosis, in which the liver is permanently damaged. Individuals with Nash are part of the 20% of adults in the U.S. who have NAFLD, or non-alcoholic fatty liver disease. AKRO YTD mountain Akero Therapeutics stock.
Persons: steatohepatitis, Eliana Merle, Akero, Nash, NASH, Merle, NASH cirrhotics, — CNBC's Michael Bloom Organizations: U.S . Food, Drug Administration, Therapeutics Locations: U.S, Nash
UBS reiterates Netflix as buy UBS said it's standing by its buy rating on shares of the streaming giant. Morgan Stanley reiterates Ambarella as overweight Morgan Stanley said it's bullish on shares of the semiconductor company heading into earnings this week. " UBS reiterates Disney as buy UBS said it's standing by its buy rating on shares of the entertainment giant. Morgan Stanley downgrades CrowdStrike to equal weight from overweight Morgan Stanley said it's cautious heading into earnings later this week. Morgan Stanley names LifeStance Health Group a top pick Morgan Stanley said shares of the behavioral health company are compelling.
Persons: Tesla, Canaccord, it's bullish, it's, Morgan Stanley, Ambarella, JMP, Piper Sandler, Piper, Bernstein, L3Harris, Evercore, Jefferies, Morgan Stanley downgrades CrowdStrike, Zimmer, BTIG, Wells, Dwight, Truist, Wolfe, Stifel, defensives Organizations: UBS, Netflix, Disney, Pagaya Technologies, MCW, OW, JetBlue, " Bank of America, Bank of America, Akero Therapeutics, RBC, Tetra Tech, Tech, Amazon, LifeStance Health, Mobility, UGI Corporation, TAM, Nike, NIKE, Endeavor Group, Media, Entertainment, Costco, AutoZone, Walmart Locations: China, Underperform, ORLY
An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith/File Photo Acquire Licensing RightsAug 26 (Reuters) - The U.S. Federal Trade Commission (FTC) has suspended its challenge of Amgen's (AMGN.O) $27.8 billion purchase of Horizon Therapeutics (HZNP.O), allowing the FTC to consider whether the agency should settle the case, a filing late on Friday showed. The FTC filed a lawsuit on May 16 aimed at stopping the transaction in a rare move to block a large pharmaceutical deal. Amgen and Horizon Therapeutics did not immediately respond to a Reuters' request for comment. Reporting by Urvi Dugar in Bengaluru; editing by Jason Neely and Diane CraftOur Standards: The Thomson Reuters Trust Principles.
Persons: Robert Galbraith, Urvi, Jason Neely, Diane Craft Organizations: REUTERS, U.S . Federal Trade Commission, Horizon Therapeutics, FTC, Horizon, Thomson Locations: South San Francisco , California, Oaks , California, Bengaluru
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Persons: Dow Jones
Big-ticket items included $150,000 red-light therapy beds and $70,000 hyperbaric chambers. It's not just tech bros who seem to be obsessed with health, wellness, and longevity trends. AdvertisementAdvertisementThe Information, a subscription tech industry news site, recently conducted an anonymous poll of 500 subscribers' health and wellness habits. At Next Level Therapeutics, a wellness center in New York City, a 15-minute NovoThor full body red light therapy session costs about $55, according to its booking page. Among the general population, wellness trends like cold plunges and red light therapy are gaining popularity as the quest to live longer increasingly goes mainstream.
Persons: It's, Jeff Bezos, Mark Zuckerberg, Elon Musk, Bryan Johnson, Dustin Giallanza, they'd, James Carroll, Thor Photomedicine, Carroll, Keith Rabois, Miami Rabois Organizations: MLB, MLS, Mayo Clinic, Venture, Founders Fund, FDA, Miami Locations: Braintree, NovoThor, New York City, Mayo
A group of hedge funds' favorite stocks trounced the broader market, thanks to the strength of mega-cap tech, according to Goldman Sachs. It then compiled a basket of the most popular long positions, dubbed Goldman's Hedge Fund VIP basket, comprising 50 stocks that most frequently appear among the largest 10 holdings of hedge funds. The VIP basket has returned 22% this year as of mid-August, outperforming the S & P 500 , which was up 15% during the same period. The largest tech stocks — Amazon , Microsoft , Google parent Alphabet and Meta Platforms — remain the most popular hedge fund long positions at the end of June. Big artificial intelligence winner Nvidia was the fifth-most popular stock among hedge funds.
Persons: Goldman Sachs, Goldman, Uber, — CNBC's Michael Bloom Organizations: Microsoft, Google, Nvidia, Activision, Apple, Horizon Therapeutics, Visa
BERLIN, Aug 23 (Reuters) - Roche (ROG.S) inadvertently published positive lung cancer drug trial data from an interim analysis, boosting the Swiss drug maker's shares even though more data will be needed to confirm the treatment's efficacy. Roche said on Wednesday that market participants had made it aware of the inadvertent disclosure of an interim data analysis on new immunotherapy tiragolumab, part of an experimental class of drugs known as anti-TIGIT. The data lifted Roche shares by 5% and sent shares of other companies testing anti-TIGIT drugs higher. J.P. Morgan analysts said the interim data suggested a survival benefit was within reach in the final analysis, but the clinical relevance remained uncertain. The unintended disclosure regards the second interim analysis of a Phase III trial known as Skyscraper 1.
Persons: Roche, tiragolumab, Morgan, Roche's, TIGIT, Paul Arnold, Christy Santhosh, Jason Neely, Friederike Heine, Mark Potter Organizations: Merck & Co, Gilead Sciences, iTeos Therapeutics, Arcus Biosciences, Thomson Locations: U.S, Zurich, Bengaluru
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Organizations: Wall Street
CVS Health logo is seen displayed in this illustration taken, May 3, 2022. The regional health insurance provider will still retain CVS Caremark for managing specialty drugs, which are costly medications used to treat complex conditions like cancer and rheumatoid arthritis. Other analysts highlighted difficulties in shifting to a different model than the one offered by companies like CVS - which provide other services including home drug delivery and reimburse pharmacies for patients' prescriptions. Amazon Pharmacy will provide at-home delivery of prescription drugs as well as upfront pricing, while Mark Cuban Cost Plus Drug Company will provide access to generic drugs, Blue Shield said. Blue Shield of California's other partners include privately held Abarca for processing claims related to prescription drugs, while smaller PBM Prime Therapeutics will work to negotiate savings with drugmakers.
Persons: Dado Ruvic, Cigna, UnitedHealth, Mark, Elizabeth Anderson, J.P, Morgan, Lisa Gill, Gill, Blue, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai, Krishna Chandra Eluri, Frances Kerry Organizations: CVS, REUTERS, Amazon, Cigna, UnitedHealth, Evercore ISI, Mark Cuban, Plus, Thomson Locations: Bengaluru
CVS Health logo is seen displayed in this illustration taken, May 3, 2022. Blue Shield, whose health plans cover 4.8 million members, said it will now work with five different companies, including Mark Cuban's drug company, to provide "convenient, transparent access to medications while lowering costs." Privately held Abarca will pay prescription drug claims, while Prime Therapeutics will work with Blue Shield to negotiate savings with drugmakers, the company said. Blue Shield will also work with CVS Caremark for specialty pharmacy services. The loss of the Blue Shield pharmacy benefit management contract is another blow to Caremark, which is also set to lose the contract to manage Centene's (CNC.N) $40 billion annual pharmacy needs from next year.
Persons: Dado Ruvic, UnitedHealth, Mark Cuban's, Paul Markovich, Mark, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai Organizations: CVS, REUTERS, Blue, Cigna, UnitedHealth, Pharmacy, Wall Street, Mark Cuban, Plus, Thomson Locations: Blue, Bengaluru
CVS Health logo is seen displayed in this illustration taken, May 3, 2022. Non-profit health plan provider Blue Shield, which has 4.8 million members, said it will work with partners including Amazon.com and Mark Cuban's Cost Plus Drug Company to provide at-home delivery and access to low-cost medications. Privately held Abarca will pay prescription drug claims, while Prime Therapeutics will work with Blue Shield to negotiate savings with drugmakers, the company said. Blue Shield will also work with CVS Caremark for specialty pharmacy services. The loss of Blue Shield marks another blow to Caremark, which is also set to lose the contract to manage Centene's (CNC.N) $40 billion annual pharmacy needs from next year.
Persons: Dado Ruvic, Cuban's, Privately, Manas Mishra, Mariam Sunny, Bhanvi, Shweta Agarwal, Pooja Desai Organizations: CVS, REUTERS, Wall Street Journal, Cigna, UnitedHealth, Company, Thomson Locations: Bengaluru
A number of studies last year demonstrated that pig kidneys that had been transplanted into brain-dead individuals made urine, an essential function, for short periods of time. “The really new finding here is that these pig kidneys can clear enough creatinine to support an adult human,” Dr. Locke said. “If you want to have life-sustaining kidney function, the kidneys have to do more than just make urine,” Dr. Locke said. A few months later, researchers at the University of Maryland transplanted a heart from a genetically modified pig into a 57-year-old patient with heart failure. So far, transplants of genetically modified pig kidneys have been made only to brain-dead patients.
Persons: , Jayme Locke, Dr, Locke Organizations: Transplant Institute, NYU Langone Health, University of Maryland, Revivicor, United Therapeutics Corporation, Langone Health, Food and Drug Administration Locations: Alabama, New York
Founded by brothers Julian and Felix Baker in 2000, the health care hedge fund focuses on biotech and life sciences investing. The biotech stock with a focus on neuroscience has surged more than 84% this year. Baker Bros. doubled down on its bet in Kymera Therapeutics , which it raised by more than 51%. The hedge fund also took new stakes in ImmunoGen , which has more than tripled this year, soaring 216%, and Day One Biopharmaceuticals , which is down by 34%. The hedge fund lowered its exposure to the biotech company, which develops treatments for cancer, by 5%.
Persons: Baker, Tisch, Julian, Felix Baker, Seagen, Yun Li Organizations: Baker Bros, Advisors, Yale, Acadia Pharmaceuticals, Kymera Therapeutics Locations: InVitae, Invitae, Acadia, ImmunoGen
Companies BioXcel Therapeutics Inc FollowAug 14 (Reuters) - BioXcel Therapeutics Inc (BTAI.O) said on Monday it will reduce its workforce by more than 50% to 80 employees from about 190, as the drugmaker shifts its focus towards developing its agitation treatment. The drug, sold under the brand name Igalmi in the U.S., is already approved for use in hospital settings to treat agitation in adult patients with schizophrenia or bipolar disorder. The company plans to reduce in-hospital commercialization expenses, and suspend trials that it no longer deems core to its business. With the job cuts, BioXcel aims to reduce more than 50% of its cash burn to about $80 million on a go-forward annualized basis. Its cash and cash equivalents totaled to $127.5 million as of June 30, compared with $165.5 million as of March 31.
Persons: Sriparna Roy, Krishna Chandra Organizations: BioXcel Therapeutics, BioXcel Therapeutics Inc, Oaktree Fund Administration, Qatar Investment Authority, Thomson Locations: U.S, Bengaluru
Companies BioXcel Therapeutics Inc FollowAug 14 (Reuters) - BioXcel Therapeutics Inc (BTAI.O) said on Monday it will reduce its workforce to 80 employees from about 190, as the drugmaker shifts its focus to treatments for agitation. The company said it will prioritize development of its drug BXCL501, being evaluated for use in at-home settings for treatment of agitation related to schizophrenia, bipolar disorders and in patients with mild-to-moderate dementia due to probable Alzheimer's disease. Shares of the company were halted during premarket trading. Reporting by Sriparna Roy in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.
Persons: Sriparna Roy, Krishna Chandra Organizations: BioXcel Therapeutics, BioXcel Therapeutics Inc, Thomson Locations: Bengaluru
Merger arbitrage investors have been struggling this year. Play the gap Merger arbitrage can be a tricky strategy for regular investors to incorporate. Investors can buy into the following funds for exposure to merger arbitrage: The Arbitrage Fund (ARBNX) The Merger Fund (MERIX) The NexPoint Merger Arbitrage fund (HMEAX) The First Trust Merger Arbitrage ETF (MARB) The IQ Merger Arbitrage ETF (MNA) To be sure, many of these funds charge a hefty fee. Kroger and Albertsons , the two largest biggest grocers by revenue, just notched a regulatory win after a judge dismissed a consumer lawsuit challenging the $25 billion merger. Tower Semiconductor is trading for around $34 a share such that the arbitrage spread stands at more than 50%.
Persons: Activision Blizzard, Andrew Beer, Dealmaking, John Orrico, Salvatore Bruno, VMware's, Black Knight, it's Organizations: Federal Trade Commission, Activision, FTC, Microsoft, Hedge Fund Research, Beta Investments, Global, Horizon Therapeutics, Activision Blizzard, Broadcom, VMware, Intercontinental Exchange, Black, CNBC, Kroger, Albertsons, Intel, Semiconductor Locations: Island, Water Island, British, Israel
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
In this photo illustration, the Sage Therapeutics logo of a biopharmaceutical company seen on a smartphone and on a pc screen. Shares of Sage Therapeutics fell more than 50% on Monday after the Food and Drug Administration approved the biotech company's oral drug zuranolone for postpartum depression, but not for major depressive disorder, a bigger potential market. The two companies also applied for approval of zuranolone for major depressive disorder, also known as clinical depression. Zuranolone had the potential for $1 billion in peak sales, compared with $250 million to $500 million for postpartum depression, Jefferies analyst Michael Yee said in a research note Sunday. He said clinical depression "was really the big upside driver here" for the companies, while postpartum depression is "much smaller and may not be hugely profitable."
Persons: Sage, Zuranolone, Jefferies, Michael Yee Organizations: Sage Therapeutics, Food and Drug Administration
REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.
Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru
A trader works on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., July 26, 2023. U.S. stocks have sharply rallied in 2023, with the benchmark S&P 500 (.SPX) clocking 17% gains year to date, fueled by optimism around artificial intelligence and hopes of a soft landing for the world's largest economy. "But in the service side, it's been pretty sticky and that's one reason why it's taking a lot longer for inflation to subside." Reuters GraphicsOverall, second-quarter earnings have been better-than-expected so far, with 79.1% of the 422 S&P 500 companies that have reported as of Friday beating analysts' estimates, according to Refinitiv data. The S&P index recorded 17 new 52-week highs and seven new lows, while the Nasdaq recorded 46 new highs and 128 new lows.
Persons: Brendan McDermid, Dow, Charlie Ripley, it's, John Williams, Michelle Bowman, Vaibhav, Zachary Kirkhorn, Berkshire Hathaway, Warren Buffett, Tyson, packer, Bansari Mayur Kamdar, Johann M, Saumyadeb Chakrabarty, Maju Samuel Organizations: New York Stock Exchange, REUTERS, Berkshire, Tyson, Dow, Nasdaq, Federal, CPI, Allianz Investment Management, York Fed, Dow Jones, Apple, Reuters, Sage Therapeutics, Tyson Foods, Yellow Corp, NYSE, Thomson Locations: New York City, U.S, Bengaluru
FDA approves oral pill for postpartum depression for first time
  + stars: | 2023-08-05 | by ( ) www.reuters.com   time to read: +2 min
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.
Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru
Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., July 26, 2023. All eyes will be squarely on the July U.S. nonfarm payrolls report, due at 8:30 a.m. ET, with a Reuters poll of economists estimating payrolls increased by 200,000 jobs last month, after having risen 209,000 in June, showing labor market conditions remain tight. "Today's NFP data would be important for setting the market tone for the coming weeks," Jefferies strategist Mohit Kumar said. ET, Dow e-minis were up 10 points, or 0.03%, S&P 500 e-minis were up 8.5 points, or 0.19%, and Nasdaq 100 e-minis were up 44.25 points, or 0.29%.
Persons: Brendan McDermid, Amazon's, nonfarm, Jefferies, Mohit Kumar, Stocks, DraftKings, Shubham Batra, Bansari, Savio D'Souza, Shounak Organizations: New York Stock Exchange, REUTERS, Apple Futures, Dow, Nasdaq, Amazon.com, Microsoft, Labor Department, Fitch, AAA, Dow e, Horizon Therapeutics, Sports, Thomson Locations: New York City, U.S, States, Bengaluru
REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder), or clinical depression, as well as postpartum depression (PPD), which affect millions of people. Analysts were anticipating the stocks of both companies to fall if the drug was approved only for postpartum depression due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an IV injection. Postpartum depression (PPD) affects around one in seven women who give birth.
Persons: Andrew Kelly, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru
The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, July 19, 2023. Pfizer is limiting the distribution of some drugs manufactured at its plant in Rocky Mount, North Carolina, after the facility was struck by a tornado last month, the company said in a letter to hospitals late Thursday. The letter listed 12 injection products that Pfizer will only distribute through emergency orders "due to their high medical need," effective "immediately and until further notice." It also includes an injection used to treat metabolic acidosis, or the buildup of excess acid in the body due to ailments like kidney failure. Pfizer said last month that the tornado primarily damaged a warehouse facility, which stored raw materials, packaging supplies and finished medicines waiting for quality assurance.
Persons: Meera Bhavsar, Albert Bourla Organizations: Pfizer, American Society of Health Locations: Rocky Mount, North Carolina
Companies Merck & Co Inc FollowAug 1 (Reuters) - Merck & Co (MRK.N) posted better-than-expected second-quarter sales on Tuesday on strong demand for its two top-selling products, cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil. Shares of Merck rose about 2% at $108.45 in premarket trading after the company also raised its full-year revenue forecast. Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion. Sales of Gardasil, which prevents cancers caused by HPV, surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. Merck said it now expects full-year sales of $58.6 to $59.6 billion, up from its prior view of $57.7 billion to $58.9 billion.
Persons: Merck, Rob Davis, Davis, Keytruda, Cantor Fitzgerald, Louise Chen, Prometheus, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, Merck & Co, Merck's, Prometheus Biosciences, Analysts, Prometheus, Thomson Locations: United States, China, U.S, New York, Bengaluru
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