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Shares of Amgen fell more than 7% Tuesday as analysts chewed over bone density loss data from an early-stage trial on its experimental weight loss injection, MariTide. Amgen did not immediately respond to a request for comment on the dataThe drug is a promising potential competitor in the weight loss drug market. "On one hand, patients could naturally lose bone mineral density during weight loss treatment," Brayer wrote. But Brayer said, "on the other hand, this could be a non-starter because there seems to be a dose-dependent increase" in bone mineral density loss. Amgen is also aware of the "hypothetical concern" of bone mineral density loss, Yee said, citing the firm's discussions with management.
Persons: Amgen, Eli Lilly, Cantor Fitzgerald, Olivia Brayer, Eli, Wegovy, Brayer, Jefferies, Michael Yee, Yee, Evan Seigerman, hasn't, Seigerman Organizations: Novo Nordisk, BMO
Gilead 's twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday. The positive phase three trial data on lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention. The company said 99.9% of participants who received lenacapavir did not acquire HIV, with two cases among 2,180 people. Gilead in June also said lenacapavir was 100% effective at preventing HIV in another late-stage trial with cisgender women. The trial results should lead to an FDA approval and launch in the market by 2025, Yee said.
Persons: Gilead, Daniel O'Day, lenacapavir, Michael Yee, Yee Organizations: U.S . Food, Drug Administration, PrEP, Centers for Disease Control, Jefferies, CNBC, YouTube Locations: Gilead
Moderna on Thursday said it plans to cut around $1.1 billion in expenses by 2027 and win approvals for several new products as it charts a path forward after the rapid decline of its Covid business. The company aims to trim R&D spending to a range of $3.6 billion to $3.8 billion in 2027, down from an expected $4.8 billion at the end of this year, according to a release. Moderna also has five non-respiratory products across cancer, latent viruses and rare diseases that could be approved by 2027, according to the company's release. The company expects 2025 revenue to come in at $2.5 billion to $3.5 billion. From 2026 to 2028, Moderna expects a compounded annual growth rate of more than 25% as new products launch.
Persons: Moderna, Stephane Bancel, Leerink, Mani Foroohar, Foroohar, Michael Yee, Bancel Organizations: Moderna, CNBC, Jefferies Locations: New York, U.S
New cancer drug data announced: Here's what to know
  + stars: | 2024-06-03 | 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 EmailNew cancer drug data announced: Here's what to knowMichael Yee, Jefferies senior biotech analyst, joins 'Squawk Box' to discuss the latest innovations at the ASCO conference last week, announcement of the latest cancer drug data, and more.
Persons: Michael Yee Organizations: Jefferies
That fueled investor concerns about new competition in the rapidly growing weight loss drug industry, sending shares of the current obesity players, Novo Nordisk and Eli Lilly , lower on Friday. Eli Lilly shares dropped nearly 3%, while Novo Nordisk's U.S.-traded shares fell more than 1%. Still, investors were pleased with Eli Lilly on Tuesday after the company assured them it can overcome ongoing supply constraints for its popular drugs. Eli Lilly hiked its full-year guidance in part due to optimism around increased production of Zepbound, its diabetes injection Mounjaro and similar drugs for the rest of the year. That signals Novo Nordisk is struggling to meet demand for the treatment.
Persons: Amgen, Eli Lilly, Bob Bradway, Bradway, Jay Bradner, autoinjector, Novo Nordisk's Wegovy, Eli Lilly's Zepbound, William Blair, Matt Phipps, Michael Yee, Amgen's Bradway, Karsten Munk Knudsen Organizations: Novo Nordisk, Novo Nordisk's, Jefferies, MariTide, Nordisk Locations: Novo Nordisk's U.S, North Carolina, Indiana, Ireland, Germany, U.S
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailWeight-loss drug frenzy: $100 billion total addressable market opportunity? Michael Yee, Jefferies senior biotech analyst, joins 'Squawk Box' to discuss the weight-loss drug frenzy, new players in the category, growth outlook for the sector, and more.
Persons: Michael Yee Organizations: Jefferies
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailPfizer's expectations have been rightsized, has potential for $5 EPS: Cantor Fitzgerald's ChenLouise Chen, Cantor Fitzgerald, and Michael Yee, Jefferies, joins 'Power Lunch' to discuss Chen's bull case for Pfizer, Yee's bull case for Moderna, and more.
Persons: Fitzgerald's Chen Louise Chen, Cantor Fitzgerald, Michael Yee, Jefferies Organizations: Pfizer, Moderna
Acute pain is usually caused by injury, surgery, illness, trauma or painful medical procedures and is likely to ease with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., Vertex said in a release. Last year, the company's painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a chronic nerve condition. Those two procedures are commonly used in studies of people with acute pain. Jefferies analyst Michael Yee said the drug's failure to meet that goal is in line with expectations and that overall, the late-stage trial results released Tuesday are positive.
Persons: Reshma Kewalramani, painkiller, Michael Yee Organizations: Vertex Pharmaceuticals, Food and Drug, Wall Street, CRISPR Therapeutics, Jefferies Locations: Boston, U.S
The results are a blow to Gilead, which is working to become a power player in the cancer space. Patients with advanced or metastatic non-small cell lung cancer who took Trodelvy lived longer than those who got chemotherapy alone, according to Gilead. The drugmaker said it will discuss the results with regulators and identify whether certain lung cancer patients may still benefit from the drug. Jefferies analyst Michael Yee said Gilead's trial results are not "totally surprising" to the firm because data from early studies was mixed and data for competing drugs was "lackluster." Yee added that the trial results could "dent" investor confidence about whether Gilead will have significant sales in oncology.
Persons: Trodelvy, Michael Yee, Yee, Gilead Organizations: Jefferies Locations: Gilead
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailPharma could see a wave of M&A activity in 2024, says Jefferies' Michael YeeMichael Yee, Jefferies senior biotech analyst, joins 'Fast Money' to talk dealmaking in the pharma sector in 2024.
Persons: Jefferies, Michael Yee Michael Yee Organizations: Email Pharma, Jefferies, pharma
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
In this article PFEMRNANVAX Follow your favorite stocks CREATE FREE ACCOUNTA sign advertises Covid vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, on Aug. 14, 2023. Brian Snyder | ReutersThree years into the Covid-19 pandemic, few Americans are rolling up their sleeves to get a Covid vaccine. Experts and vaccine makers can agree that low Covid vaccination rates are concerning, even as cases of the virus dwindle from their pandemic highs. However, Iovine of the University of Florida doesn't believe combination shots will have a significant effect on Covid vaccination rates. If combination shots don't do the trick, it's unclear what else could boost Covid vaccination rates down the line.
Persons: Brian Snyder, Ali Mokdad, Mokdad, Irfan Khan, Jennifer Kates, Brad Pollock, Nicole Iovine, epidemiologist, Iovine, Michael Yee, Albert Bourla, Arpa Garay, Garay, John Trizzino, Trizzino, Jamey Mock, Andrew Pekosz, Jefferies, Yee, doesn't Organizations: Walgreens, Reuters, Pfizer, Moderna, Centers for Disease Control, CDC, University of Washington, CVS Pharmacy, Los Angeles Times, KFF, UC Davis Health's, University of Florida, Jefferies, Arpa, CNBC, Istock, Getty, Johns Hopkins Bloomberg School of Public Health Locations: Somerville , Massachusetts, U.S, Novavax, Covid, Eagle Rock , California
Syringes with needles are seen in front of a displayed Moderna logo in this illustration taken, November 27, 2021. Around 20 million people need to be vaccinated with Moderna's updated COVID-19 vaccine for the company to reach $2 billion in 2023 sales from the private market, a figure four analysts told Reuters was achievable. The company has said it expects total U.S. COVID vaccine demand to be as much as 100 million doses in the fall season. Moderna forecast $6 billion to $8 billion for sales of its COVID-19 vaccine in 2023, $2 billion to $4 billion of which is expected to come from the commercial market. The COVID vaccine is Cambridge, Massachusetts-based Moderna's lone marketed product.
Persons: Dado Ruvic, Oppenheimer, Hartaj Singh, Michael Yee, Yee, Manas Mishra, Khushi, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, Reuters, U.S, Moderna, Pfizer, Jefferies, GSK, Thomson Locations: Cambridge , Massachusetts, United States, Bengaluru, New
Third quarter sales of Horizon's gout drug Krystexxa rose to $253 million from $192 million. Amgen raised its post-acquisition forecast for full-year sales to between $28 billion and $28.4 billion from a previous estimate of $26.6 billion to $27.4 billion. Total revenue for the quarter rose 4% to $6.9 billion, in line with analyst expectations. Sales of cancer drug Lumakras fell 31% to $52 million and sales of psoriasis drug Otezla fell 10% to $567 million. Sales of Amjevita, Amgen's new biosimilar version of AbbVie's (ABBV.N) blockbuster arthritis drug Humira, rose 30% to $152 million.
Persons: Robert Galbraith, Amgen, Jefferies, Michael Yee, Bill Smead, Tepezza, We're, we've, Peter Griffith, AMG340, William Blair, Matt Phipps, Lumakras, Otezla, Deena Beasley, Leroy Leo, Bill Berkrot Organizations: REUTERS, Horizon Therapeutics, Smead Capital Management, Wall Street, U.S . Federal Trade Commission, Thomson Locations: South San Francisco , California, California, Los Angeles, Bengaluru
Vaccine makers are depending on the U.S. market as many countries have more limited yearly campaigns for giving updated shots. For BioNTech, Moderna, and Novavax (NVAX.O), COVID vaccines remain their only approved products. Shares of Pfizer were up nearly 5%, however, buoyed by a $3.5 billion cost-cutting plan the drugmaker announced late on Friday alongside its new COVID sales outlook. Moderna, in a statement on Monday, maintained its current revenue forecast of $6 billion to $8 billion for its COVID vaccine for 2023. Jefferies analyst Michael Yee said Pfizer's new COVID outlook implies lower vaccine sales for Moderna than it had forecast.
Persons: Dado, BioNTech, Albert Bourla, Bourla, Mani Foroohar, Foroohar, Jefferies, Michael Yee, Ludwig Burger, Rachel More, Michael Erman, Bhanvi Satija, Manas, Jonathan Oatis, Caroline Humer, Bill Berkrot Organizations: COVID, Institute for Health, Food, REUTERS, Pfizer, Moderna, Manas Mishra, Thomson Locations: Zenica, Bosnia, Herzegovina, Frankfurt, Novavax, U.S, New York, Bengaluru
Moderna flu shot succeeds in late-stage study
  + stars: | 2023-09-13 | by ( Patrick Wingrove | ) www.reuters.com   time to read: +4 min
The effectiveness of Moderna's flu vaccine was demonstrated across all age groups, including older people, and was found to be safe and tolerable, according to the company. Moderna also said it had found that its shot was equal or superior to Sanofi's high-dose flu vaccine in a separate early head-to-head study. Following the U.S. Food and Drug Administration's authorization on Monday, Moderna said it would start shipping COVID vaccine doses across the United States. "The vaccine's manufacturing runs from June to October and we are already producing it. All the purchase orders are being fulfilled," a Rovi spokesperson said, referring to the COVID vaccine.
Persons: Dado Ruvic, Moderna, Jefferies, Michael Yee, Stephen Hoge, Hoge, we've, We've, COVID, Spain's, Patrick Wingrove, Will Dunham, Mark Porter Organizations: REUTERS, Moderna, U.S . Centers for Disease Control, U.S . Food, Sanofi, Thomson Locations: United States, Moderna, Massachusetts, Britain, Canada, Japan, China, New York, Bengaluru
An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. With Horizon, Amgen acquires drugs that won't be affected by new U.S. negotiation requirements for blockbuster medications as well as possible tax advantages stemming from Horizon's headquarters in Ireland. Analysts said the Horizon deal could also help Amgen's tax situation. The United States has largely eliminated once-lucrative corporate tax benefits for pharmaceutical manufacturing operations in Puerto Rico, a U.S. territory. Horizon offers Amgen "potentially a better tax jurisdiction related to Irish manufacturing plants ... Amgen has a new manufacturing process they could potentially move there," Cowen's Werber said.
Persons: Robert Galbraith, Abiel Garcia, John Kness, Donald Trump, Garcia, Evan Seigerman, Lina Khan, Cowen, Biden, Michael Yee, Amgen, Cowen's Werber, Deena Beasley, Peter Henderson, Paul Simao Organizations: REUTERS, U.S . Federal Trade, Horizon Therapeutics, U.S, District, Federal, Activision, Horizon, Amgen, BMO Capital Markets, FTC, Reuters, U.S . Food, Drug Administration, Jefferies, Medicare, Internal Revenue Service, United, Thomson Locations: South San Francisco , California, Amgen, Kesselman, Ireland, U.S, Puerto Rico, United States, Irish
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailCovid is going to be a problem for the stocks of vaccine makers, says Jefferies' Michael YeeMichael Yee, Jefferies senior biotech analyst, joins 'Squawk Box' to discuss the market performance of Covid vaccine stocks, as companies prepare to roll out new modified boosters to combat new variants, and more.
Persons: Jefferies, Michael Yee Michael Yee Organizations: Jefferies
Some public health experts hope that Americans will welcome the new shot as they would a flu jab. In the fall of 2022, by which time most people had either had the COVID virus or the vaccine, fewer than 50 million people got the shots. Its biggest rival, Moderna, conceded demand could be as few as 50 million shots. POST PANDEMIC VACCINEThe COVID public health emergency ended in May and the government has handed much of the duty of vaccinating America to the private sector. As with the flu, Pfizer (PFE.N)/BioNTech SE (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O), have created versions of the COVID vaccine to try to match the variant they believe will be circulating this fall.
Persons: Dado Ruvic, Ashley Kirzinger, Kirzinger, BioNTech, Jefferies, Michael Yee, " Yee, Mandy Cohen, William Schaffner, Schaffner, David Boulware, Michael Erman, Caroline Humer, Diane Craft Organizations: REUTERS, CVS Health, Family, Reuters, Pfizer –, Moderna, Pfizer, U.S . Centers for Disease Control, Prevention, CDC, U.S . Food, Drug Administration, EG, Vanderbilt University, University of Minnesota, Thomson Locations: U.S, America, United States, COVID, CDC's
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
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
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailBiogen's Alzheimer's drug is the biggest growth catalyst for the stock, says Jefferies' YeeMichael Yee, Jefferies biotech analyst, joins 'Power Lunch' to discuss what Biogen's purchase of Reata means for the former, the biggest catalyst for Biogen stock, and more.
Persons: Jefferies, Yee Michael Yee Organizations: Jefferies
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailBiogen shares fall after Alzheimer's drug approval. Here's what the pros are sayingMichael Yee of Jefferies, Chris Raymond of Piper Sandler, Kevin Simpson of Capital Wealth Planning, Steve Weiss of Short Hills Capital and Jim Lebenthal of Cerity Partners discussed Biogen after the FDA approved its Alzheimer's drug.
Persons: Michael Yee, Jefferies, Chris Raymond, Piper Sandler, Kevin Simpson, Steve Weiss, Jim Lebenthal Organizations: Capital Wealth, Short Hills Capital, Cerity Partners, FDA
Sales of the Alzheimer's drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S.Wall Street is chewing over the Food and Drug Administration's Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn't a cure. Leqembi, from drugmakers Eisai and Biogen , is the first medicine proven to slow the progression of Alzheimer's in people at the early stages of the memory-robbing disease. Yee added that the firm's channel checks suggest doctors see the registry requirement "as a potential real-world challenge – at least in the initial phase." That includes navigating Medicare's registry requirement and coordinating PET scans and MRIs to screen for dangerous side effects of the drug. But Goodman, like other analysts, also noted that "we continue to expect a slow ramp in 2023 and acceleration moving into 2024."
Persons: Jay Reinstein, drugmakers, Yatin Suneja, Jefferies, Michael Yee, Yee, Paul Matteis, Marc Goodman, Goodman Organizations: Georgetown University Hospital, Wall, Food, Leqembi, FDA, National Institute, Aging, ARIA, SVB Securities Locations: Washington , DC, U.S
June 6 (Reuters) - Novocure Ltd's <NVCR.O> experimental device to treat a type of lung cancer helped in extending overall survival among patients in a late-stage study, but concerns around its commercial success sent the medical device maker's shares down more than 34% on Tuesday. The device, used with certain chemotherapies and immunotherapies, helps in creating electric fields that disrupt cancer cell growth. Data from the study shows that the device, along with a class of immunotherapies know as immune checkpoint inhibitors (ICI), extended survival by about eight months, compared to patients treated with ICI alone. Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for about 85% of all lung cancers, the company said. Reporting by Khushi Mandowara in Bengaluru; Editing by Nivedita Bhattacharjee, Shinjini Ganguli and Maju SamuelOur Standards: The Thomson Reuters Trust Principles.
Persons: Emily Bodnar, Jefferies, Michael Yee, Novocure, Khushi, Nivedita Bhattacharjee, Shinjini, Maju Samuel Organizations: ICI, Wainwright, U.S . Food, Drug Administration, Thomson Locations: United States, U.S, Bengaluru
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