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Here's a rapid-fire update on all stocks in Jim Cramer's Charitable Trust, the portfolio we use for the CNBC Investing Club. But for investors who haven't bought into its steep pullback, it's reasonable to buy some shares at current levels around $146.50 each. Unless you believe inflation is going to keep raging, making Microsoft's price-to-earnings multiple too high, then this stock is a buy. Nvidia (NVDA): Investors who don't own Nvidia yet should use its recent weakness to start a position, Jim said. Pioneer Natural Resources (PXD): We decided to buy additional Pioneer shares Thursday as the stock fell more than 2%.
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Eli Lilly on Monday said it applied for full U.S. Food and Drug Administration approval of its Alzheimer's treatment, donanemab, and expects the agency to make a decision by the end of the year. "The earlier you begin to use the drug perhaps the more slowing that can be," Eli Lilly CEO David Ricks said in an interview on CNBC's "Squawk on the Street" on Monday. Eli Lilly is among the pharmaceutical companies racing to market new treatments for the disease after Eisai and Biogen's drug Leqembi won FDA approval this month. The agency's signoff on Leqembi was a milestone in the treatment of Alzheimer's, even though the drug and donanemab aren't cures. An FDA approval of Eli Lilly's donanemab would expand the treatment options for the more than 6 million Americans of all ages who have Alzheimer's, the fifth-leading cause of death for adults over 65.
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Here's a deeper look at the headlines and their implications for our investment theses in these two health-care companies. The Club's take: The first-of-their-kind FDA and CMS actions came in generally as anticipated, and represent incremental positives for Eli Lilly. That's why some of the decline seen Friday in Eli Lilly shares – down over 2%, to around $453 each – could simply represent a sell-the-news situation. Eli Lilly has said donanemab could be approved by the FDA late this year or in early 2024. Our expectations around donanemab sales also are measured, and the drug is not the primary driver of our multiyear optimism for Eli Lilly.
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Biogen isn't worried about competing with Eli Lilly as they both attempt to bring an Alzheimer's drug to the market, Biogen's CEO said Tuesday. Researchers argue that the accumulation of amyloid plaque is a crucial first step toward the cognitive decline observed in Alzheimer's disease. Eli Lilly didn't immediately respond to a request for comment. He said that will likely require Eli Lilly and Biogen to roll out maintenance doses that will keep plaque levels low. Biogen is banking on the success of its drug leqembi after the disastrous approval and rollout of its old Alzheimer's drug aduhelm last year.
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.
Alzheimer's patients who take Leqembi retain the benefits of the treatment even when they stop taking it, new research by Eisai shows. The findings also come as Eisai and Biogen try to regain their footing after the polarizing approval and disastrous rollout of its other Alzheimer's disease therapy, aduhelm, last year. In the analysis, Alzheimer's patients stopped taking Leqembi after 18 months in a phase two clinical trial and later resumed the treatment in an extension trial. Amyloid is a protein that builds up on the brain in Alzheimer's patients and disrupts cell function. That means Alzheimer's disease progressed at a slower rate in patients who received Leqembi compared to those who took the placebo during the clinical trial.
But amid some positive news, companies focused on Alzheimer's have said they've received an influx of investor interest. In trials, Leqembi was found to slow the rate of cognitive decline by 27% in Alzheimer's patients over 18 months. Eli Lilly's drug donanemab is expected to have data soon but just faced a setback from the FDAEli Lilly's donanemab is the focus of a late-stage trial. In the first half of this year, Eli Lilly is expected to release data for its Alzheimer's drug donanemab, which is being tested in a late-stage trial. Getty ImagesAduhelm, the first Alzheimer's drug to be approved in 18 years, was OK'd by the FDA in 2021 but has faced controversy.
Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. Nearly all Alzheimer's drugs, including those targeting amyloid, have stumbled in trials. Late-stage data on gantenerumab is expected by the fourth quarter, Roche said in a statement, saying it was encouraged by the lecanemab data. Results of a key late-stage trial testing the drug are anticipated by mid-2023. AMYLOID HYPOTHESISSome researchers, including Frederiksen, are cautiously optimistic about the impact the Biogen, Eisai data has on the likelihood of success for the other two drugs in development.
Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer's drug, were up 6.7% in after hours trade. Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry. Symptomatic brain swelling was seen in 2.8% of those in the lecanemab group and none of the placebo group, they said. Aduhelm's approval was a rare bright spot for Alzheimer's patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost. Other plaque-targeting antibodies in late-stage development for Alzheimer's patients include Roche Holding AG's (ROG.S) gantenerumab and Eli Lilly's donanemab.
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