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Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

☆ FDA approves Alzheimer’s drug Leqembi, paving way for broader Medicare coverage
▼ + stars: | 2023-07-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +8 min

Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer's disease. Medicare coverage is a crucial step to help older Americans with early Alzheimer's disease pay for the treatment. Costs may vary depending on whether the patient has supplemental Medicare coverage or other secondary insurance, according to the agency. Philipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of Alzheimer's antibody treatments by one year would result in $6.8 billion in increased spending.

Persons: Joanna Pike, Leqembi, Pike, David Knopman, Knopman, Anna Eshoo of, Nanette Barragan, There's, Tomas Philipson, Bush, Philipson, Sen, Bernie Sanders, Xavier Becerra, Sanders, Eisai Organizations: Drug Administration, Medicare, FDA, Alzheimer's Association, Mayo Clinic, Services, Health, University of Chicago, Senate Health, Human Services, Clinical Locations: U.S, Minnesota, Anna Eshoo of California

☆ Alkermes wins battle against Sarissa in closely watched boardroom fight
▼ + stars: | 2023-06-29 | by ( Svea Herbst-Bayliss | ) www.reuters.com time to read: +3 min

NEW YORK, June 29 (Reuters) - Alkermes (ALKS.O) beat back activist investor Sarissa Capital Management's boardroom challenge on Thursday when shareholders re-elected all of the biotechnology company's directors in one of the year's most closely watched votes. But investors stuck by the company, which is valued at $5.4 billion, and returned all directors to their seats on the 11-member board. Glass Lewis, ISS's smaller rival, recommended shareholders back all Alkermes directors. Biogen shareholders this week elected Denner's romantic partner, Susan Langer, to fill his seat on the Biogen board after the board had nominated her. Both ISS and Glass Lewis referenced the Biogen matter in their recommendations on how to vote at Alkermes.

Persons: Alkermes, Nancy Wysenski, Sarah Schlesinger, Glass Lewis, Alex Denner, Susan Langer, Schlesinger, Sarissa, Svea Herbst, Bayliss, Chris Reese Organizations: YORK, Capital, Services, ISS, Svea, Thomson Locations: Alkermes, Biogen

☆ Medicare offers details on reimbursement for new Alzheimer's drugs
▼ + stars: | 2023-06-22 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

CHICAGO, June 22 (Reuters) - The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's drug Leqembi, should it win traditional U.S. approval as expected by July 6. If it wins traditional FDA approval, Leqembi would be the first disease-modifying drug ever to achieve the regulatory milestone. Current treatments only treat symptoms but do not change the course of the disease, which affects 6 million Americans, according to the Alzheimer's Association. On that basis, CMS said it would only pay for Leqembi if patients were enrolled in a clinical trial. The CMS data requirements apply to all Alzheimer's treatments that reduce beta amyloid from the brain, including Eli Lilly and Co's donanemab, which recently reported positive results from its late-stage trial.

Persons: Biogen, Eisai's Leqembi, Leqembi, Eli Lilly, Co's, “, Robert Egge, Julie Steenhuysen, Daniel Wallis Organizations: U.S, Eisai Co, Centers, Medicare, Medicaid Services, CMS, Alzheimer's Association, U.S . Food, Drug Administration, FDA, Alzheimer’s Association, Thomson Locations: U.S

☆ Sarissa's Denner quits Biogen board as firm seeks seats at Alkermes
▼ + stars: | 2023-06-14 | by ( Svea Herbst-Bayliss | ) www.reuters.com time to read: +3 min

The hedge fund's founder, Alex Denner, 53, one of three Sarissa candidates running for seats on Alkermes' 11-member board, on Monday said he would give up his board seat at biotech company Biogen (BIIB.O). The move eliminates "any claim of conflict whatsoever," Sarissa wrote to Alkermes shareholders on Tuesday. Alkermes shareholders will vote on directors on June 29 in what is one of the year's five biggest boardroom challenges. A Biogen representative confirmed that the board knew about the relationship between Denner and Langer. Denner, who has served on the Biogen board since 2009 and headed the nominating and governance committee, had nominated Langer.

Persons: Alex Denner, Sarissa, Biogen, Susan Langer, Alkermes, Denner, Langer, Bob Langer, Biogen's, Stelios Papadopoulos, Caroline Dorsa, Richard Mulligan, William Jones, Svea Herbst, Bayliss, Bill Berkrot, Mark Porter, Leslie Adler Organizations: YORK, Management, Moderna, Svea, Thomson Locations: Alkermes, Biogen

Lifted by gains in market heavyweights including increases in both Amazon (AMZN.O) and Tesla (TSLA.O), the S&P 500 has now recovered over 20% from its October 2022 lows. "The further out the October lows get in the rear view mirror, the more confident investors become. According to preliminary data, the S&P 500 (.SPX) gained 40.33 points, or 0.94%, to end at 4,339.19 points, while the Nasdaq Composite (.IXIC) gained 202.78 points, or 1.53%, to 13,461.92. The U.S. Labor Department's consumer price index reading on Tuesday is expected to show inflation cooled slightly in May, with core prices likely remaining sticky. Goldman Sachs on Friday raised its year-end price target for the benchmark S&P 500 (.SPX) to 4,500 from 4,000, citing the broadening of the market rally.

Persons: that's, Jake Dollarhide, Tesla, There's, Dylan Kremer, Goldman Sachs, Morgan, Shristi Achar, Sruthi Shankar, Noel Randewich, Vinay Dwivedi, Sriraj Kalluvila, David Gregorio Our Organizations: Nasdaq, Oracle, Longbow, Management, Dow Jones, U.S, Labor, Traders, Nasdaq Inc, FDA, Broadcom, Reuters, VMware, Thomson Locations: Tulsa , Oklahoma, megacap, Philadelphia, Bengaluru, Oakland, Calif

☆ Futures rise as focus shifts to inflation data, Fed meet
▼ + stars: | 2023-06-12 | by ( ) www.reuters.com time to read: +3 min

Goldman Sachs on Friday raised its year-end price target for the benchmark S&P 500 (.SPX) to 4,500 from 4,000, citing the broadening of the market rally. The CBOE volatility index (.VIX) edged up after hitting pre-pandemic levels in the previous week, up 0.71 point to 14.5. Adobe (ADBE.O) shares gained 1.9% after Jefferies raised the Photoshop maker's price target to $530, the second highest on Wall Street. Oracle (ORCL.N) rose 4.1% as J.P. Morgan hiked its price target to $109, ahead of the cloud and enterprise software firm's fourth-quarter results later in the day. Nasdaq Inc (NDAQ.O) slid 7.5% after the exchange operator said it would buy Thoma Bravo-owned software firm Adenza for $10.5 billion.

Persons: Goldman Sachs, stoking, Jefferies, Morgan, Thoma, Shristi Achar, Vinay Dwivedi Organizations: Dow, Nasdaq, U.S, Labor, Traders, Dow e, FDA, . Oracle, HK, Nasdaq Inc, Thoma Bravo, Thomson Locations: megacap, Nio, Bengaluru

"Until we see several months of low or declining inflation, the headline number is still going to be above the 2% target that the Fed has set. Goldman Sachs on Friday raised its year-end price target for the benchmark S&P 500 (.SPX) to 4,500 from 4,000, citing the broadening of the market rally. Oracle (ORCL.N) advanced 4.3%, hitting an all-time high as J.P. Morgan hiked its price target to $109, ahead of the cloud and enterprise software firm's fourth-quarter results later in the day. Technology stocks (.SPLRCT) led gains among the 11 major sectors of the S&P 500 while energy stocks (.SPNY) fell 0.5%, tracking a decline in crude prices. Adobe (ADBE.O) shares gained 1.6% after Jefferies increased the Photoshop maker's price target to $530, the second highest on Wall Street.

Persons: Melissa Brown, Goldman Sachs, Morgan, Thoma, Jefferies, Shristi Achar, Sruthi Shankar, Vinay Dwivedi Organizations: Nasdaq, Dow, Oracle Corp, U.S, Labor, Traders, Oracle, Dow Jones, Nasdaq Inc, Thoma Bravo, FDA, NYSE, Thomson Locations: megacap, Bengaluru

All six advisers on the panel voted in favor of Leqembi for treatment of the mind-wasting illness. That approval would also make Leqembi the first disease-modifying drug ever to achieve the regulatory milestone. Leqembi won accelerated approval by the FDA in January based on its ability to remove sticky amyloid plaques from the brain. Most U.S. Alzheimer's patients are Medicare-eligible. “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks."

Persons: Eisai, Leqembi, Tanya Simuni, Robert Alexander, Joanne Pike, Leroy Leo, Khushi, Julie Steenhuysen, Bill Berkrot Organizations: Food and Drug Administration, Alzheimer's Association, FDA, Northwestern University Feinberg School of Medicine, Banner Alzheimer's Institute, CAA, Medicare, Wall Street, Analysts, Alzheimer's, Thomson Locations: Leqembi, U.S, Bengaluru, Chicago

☆ Medicare will require data on patient use for approved Alzheimer's drugs
▼ + stars: | 2023-06-01 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +3 min

Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.

Persons: Biogen, Leqembi, Eisai, Eli Lilly, Co's, Eli Lilly's, Alzheimer's, Sue Peschin, Manas Mishra, Leroy D'souza, Bill Berkrot Organizations: U.S, Eisai Co, FDA, Medicare, Centers, Medicaid Services, CMS, Alzheimer’s Association, Alliance for Aging Research, Thomson Locations: Bengaluru

We are selling 50 shares of Eli Lilly (LLY) at roughly $442 each. Following Monday's trade, Jim Cramer's Charitable Trust will own 150 shares of LLY, decreasing its weighting in the portfolio to about 2.5% from 3.33%. We're taking some Eli Lilly off the table Monday afternoon on the stock's breakout to another new all-time high. The FDA in early January granted accelerated approval to a drug similar to donanemab, which was developed by Japanese pharmaceutical firm Eisai and U.S.-based partner Biogen (BIIB). Like Pfizer's drug, Lilly is working on an oral type-2 diabetes and chronic weight management drug called orforglipron, which could be similar to the Mounjaro injectable.

We're initiating a position in GE Healthcare (GEHC), buying 325 shares at roughly $79 each. GE Healthcare is the global leader in medical imaging, diagnostics, and digital solutions. GE Healthcare is one of the global leaders in Precision Diagnostics with an industry-leading injectable pharmaceutical portfolio in contrast media and molecular imaging. GE Healthcare is one of a few companies that offer a full suite of products and solutions to support patients. GEHC YTD mountain GE Healthcare YTD performance Analysts see GE Healthcare growing EPS to $4.33 in 2024, about a 15% increase from this year's outlook.

☆ After weight loss, Alzheimer's may be next frontier for drugs like Ozempic
▼ + stars: | 2023-05-08 | by ( Natalie Grover | ) www.reuters.com time to read: +6 min

LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.

☆ Positive Alzheimer's drug trial data pushes Eli Lilly shares to another all-time high and brightens our outlook
▼ + stars: | 2023-05-03 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +7 min

LLY 1Y mountain Shares of Eli Lilly over the past 12 months. The FDA granted accelerated approval to an anti-amyloid drug — developed by Japanese pharmaceutical firm Eisai and U.S.-based partner Biogen (BIIB) — in early January. For Eli Lilly, specifically, Seigerman said the donanemab data appears to be a "home run." Eli Lilly said two participants in the Phase 3 trial died due to ARIA side effects, while a third patient did after a serious ARIA incident. The Eli Lilly logo is shown on one of the company's offices in San Diego, California, September 17, 2020.

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

PANW YTD mountain Palo Alto Networks YTD About half of the funds raised from this Lilly sale will go into building up our position in Palo Alto Networks . But here is our problem with reading too much into the conference calls of Tenable and Cloudfare and extrapolating that to Palo Alto. While it is highly likely that deal uncertainty increased out of the regional banking crisis, Palo Alto Networks is in a special class within the industry because it is taking share from the little guys. As a market leader in thirteen categories within security, Palo Alto is a winner from what is happening in the market. And with a management team committed to profitable growth and accelerating leverage in the business, we think Palo Alto Networks will continue to surprise to the upside.

☆ Here are Monday's biggest analyst calls: Apple, JPMorgan, Zillow, General Motors, Exxon, Tesla & more
▼ + stars: | 2023-05-01 | by ( Michael Bloom | ) www.cnbc.com time to read: +5 min

Here are Monday's biggest calls on Wall Street: Morgan Stanley upgrades General Motors to overweight from equal weight Morgan Stanley said the auto giant's stock is oversold. Guggenheim initiates Endeavor as buy Guggenheim initiated the sports and entertainment company and says it's "well positioned." Morgan Stanley reiterates Tesla as overweight Morgan Stanley said Tesla's price cuts are the best measure of electric vehicle demand. Morgan Stanley upgrades Logitech to equal weight from underweight Morgan Stanley upgraded the stock mainly on valuation. Guggenheim upgrades Teradata to buy from neutral Guggenheim upgraded the software company based on positive channel checks.

☆ Alzheimer’s patients may wait years to get treated with new drugs, putting them at risk of more severe disease
▼ + stars: | 2023-04-30 | by ( Spencer Kimball | ) www.cnbc.com time to read: +17 min

But time spent waiting robs early patients of their memory and ability to live independently. This condition is often, though not always, a sign of early Alzheimer's disease. PET scans cumbersomeTwo types of tests can diagnosis Alzheimer's disease: PET scans and spinal taps. Early Alzheimer's disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. He believes big players like CVS will provide infusions for Alzheimer's disease on a major scale if they see there's a large and stable market.

☆ Big Tech earnings, crucial inflation call — here comes the biggest week of earnings season
▼ + stars: | 2023-04-22 | by ( Zev Fima | ) www.cnbc.com time to read: +9 min

Stocks stuck to a holding pattern this week as investors brace for an incoming wave of Big Tech earnings and the Fed's favorite inflation reading. Earnings reports have generally been better than expected so far this first quarter. Humana (HUM) reports before the bell Wednesday; Meta Platforms and Pioneer Natural Resources (PXD) report after the bell Wednesday. ET: Personal Spending & Income (includes PCE Price Index) Club trades this week Just one trade: We added 150 shares of Coterra Energy (CTRA) on Wednesday. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade.

☆ Eli Lilly jumps to all-time highs on Alzheimer's news. Here's what it means our investment
▼ + stars: | 2023-04-21 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +6 min

LLY 1Y mountain Shares of Eli Lilly over the past 12 months. Still, a commercially successful Alzheimer's drug would be material for Eli Lilly and strengthen its long-term position. Mounjaro is the heart of our Eli Lilly investment case. Another catalyst looming for Eli Lilly shares is results from a study conducted by its competitor in the weight-loss category Novo Nordisk . Eli Lilly Pharmaceutical company logo SOPA Images | LightRocket | Getty Images

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

☆ 'It totally backfired': The pitfalls of Alzheimer's genetic testing
▼ + stars: | 2023-04-21 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +8 min

CHICAGO, April 21 (Reuters) - Wendy Nelson watched her mother slowly die of Alzheimer's disease, unable to move or swallow at the end. When her father's memory began to fail a year later, one of her two sisters doubted it could be Alzheimer's, Nelson said. THE TESTING REVOLUTIONUntil recently, most doctors tended not to order genetic tests to determine Alzheimer's risk, because there were no effective treatments to slow or prevent the disease. US regulators recommend genetic testing before starting treatment with Leqembi. Some members of families with increased genetic risk of Alzheimer's say it might be better not to know at all.

☆ Here are Monday's biggest analyst calls: Tesla, Netflix, Zoom, Biogen, Okta, Amazon, HP Inc. & more
▼ + stars: | 2023-04-17 | by ( Michael Bloom | ) www.cnbc.com time to read: +8 min

JPMorgan upgrades HP Inc. to overweight from neutral JPMorgan said in its upgrade of HP Inc . that it sees "resilient revenue and margins." JPMorgan upgrades Ollie's to neutral from underweight JPMorgan said it has more confidence in management's same-store sales guide. JPMorgan downgrades Dell to neutral from overweight JPMorgan said in its downgrade of Dell that HP Inc. is better positioned right now. JPMorgan reiterates Amazon as overweight JPMorgan said it came away "incrementally positive" from Amazon's investor letter last week. JMP downgrades Penn to market perform from market outperform JMP downgraded the stock mainly on valuation.

☆ Jim Cramer's top 10 things to watch in the stock market Wednesday: New dawn for JNJ, Disney push, Meta upgrade
▼ + stars: | 2023-04-05 | by ( Jim Cramer | ) www.cnbc.com time to read: +4 min

Meta Platforms (META) price target raised to $250 from $225 at Jeffries. Federal Realty (FRT) price target lowered to $111 from $118 at Piper Sandler. Bank of America raises price target for Apple to $168 from $158, keeps a neutral rating on shares. 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.

☆ Club meeting recap: Jim Cramer says 'the existential threat is gone for J&J'
▼ + stars: | 2023-04-05 | by ( Paulina Likos | ) www.cnbc.com time to read: +3 min

Every weekday the CNBC Investing Club with Jim Cramer holds a "Morning Meeting" livestream at 10:20 a.m. Jim Cramer said Wednesday that J & J's proposal could mean, "the existential threat is gone for J & J." Watch Eli Lilly Club holding Eli Lilly (LLY) will report a key phase-3 data readout of its Alzheimer's drug Donanemab in the next one-to-two months. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER .

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