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FDA approval of Eli Lilly’s Alzheimer’s drug cements our decision to not take profits

INBV News by INBV News
July 4, 2024
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FDA approval of Eli Lilly’s Alzheimer’s drug cements our decision to not take profits
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Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street. Rally in markets: Stocks were higher across the board Tuesday afternoon, led by the Nasdaq Composite , which added 0.7% and was on pace for back-to-back record closes. The S & P 500 , which had been hovering near the flatline in earlier within the session, advanced around 0.4%. Shaking off earlier losses, the Dow Jones Industrial Average added about 100 points, or 0.25%. Big news for Lilly: The Food and Drug Administration on Tuesday approved Eli Lilly’s Alzheimer’s treatment donanemab. The drug might be sold under the brand name Kisunla and value $32,000 for a 12-month course. Shares of Eli Lilly moved off session lows on the news. The stock was under more pressure earlier within the day resulting from President Joe Biden and Vermont Sen. Bernie Sanders criticizing the fee of the corporate’s fast-growing weight-loss drug Zepbound. Kisunla isn’t expected to be a major driver of growth for Eli Lilly this yr or into 2025, especially when considering the billions of dollars in projected sales for Zepbound and its sister drug Mounjaro, which shares an lively ingredient, tirzepatide, and is used to treat type 2 diabetes. Still, we’ve viewed the FDA approval of Lilly’s Alzheimer’s drug as a very important catalyst for the corporate to attain a $1 trillion market value . Analysts see $477 million of sales for Kisunla in 2025 and roughly $1 billion in 2026, in accordance with FactSet. And already, Lilly has next-generation treatments to succeed Kisunla within the works. Lilly had hoped for Kisunla to be approved by the tip of March, however the timeline was pushed back after the FDA surprisingly called a gathering of an advisory panel to take a better take a look at the protection and efficacy data. The 11-member panel eventually met in June and offered unanimous support for the drug . Tuesday’s approval represents a serious breakthrough in Eli Lilly’s expensive, decadeslong pursuit of treatments for Alzheimer’s , a memory-robbing disease afflicting thousands and thousands of Americans. Before Kisunla, Lilly had come up short on multiple other experimental drugs, most notably solanezumab, which failed a high-profile late-stage study in 2016 . The corporate officially ended development of that drug last yr. Lilly’s Kisunla is the second treatment of its kind to receive full FDA approval, following within the footsteps of Biogen and Eiasi’s co-developed Leqembi in July 2023. The drugs seek to slow the disease progression in the same way by reducing the buildup of so-called amyloid plaques on a patient’s brain. These abnormal clumps of the amyloid protein have long been an indicator of Alzheimer’s disease, though their exact role within the condition isn’t known. Each drugs are administered intravenously. Leqembi has encountered a slower-than-expected rollout because the U.S. health-care system worked to ascertain infrastructure to support this recent class of treatment. Patients have to first see a health care provider who can determine their eligibility for the anti-amyloid drug. Then, IV infusions have to be scheduled to deliver the drug every two weeks together with periodic MRI scans to observe the negative effects, which include brain swelling and bleeding. Leqembi is expensive, at greater than $26,000 a yr, so ensuring insurance reimbursement is in place has been one other essential piece to the treatment puzzle. Biogen said in late April that uptake of Leqembi is accelerating, and executives offered encouraging commentary about hospital systems becoming higher equipped to handle patients on the drug. Lillly’s entrance into the Alzheimer’s market may further speed up that progress, in accordance with Alisha Alaimo, the top of Biogen’s North America business. “In an area like this, where there was such a heavy lift by the physician community, a competitor or another choice is all the time really a very good thing,” Alaimo said at a Goldman Sachs health-care conference June 12. “It’s a very good thing for physicians. It’s a very good thing for patients. But, more importantly, the market will develop faster with Lilly in play.” We had debated taking profits in Eli Lilly earlier Tuesday but ultimately decided against it because any elevated political risk from Washington within the short run doesn’t change the long-term story for the pharmaceutical giant. We have been saying for years its growth prospects were the very best amongst large-cap peers, anchored by Mounjaro and Zepbound, and now Kisunla can officially be considered a part of the story. Corona on tap: Club holding Constellation Brands is ready to report quarterly results before the bell on Wednesday. The post-earnings conference call is ready for 10:30 a.m. ET. While there was some concern about poor weather around Memorial Day impacting Constellation’s quarter, several analysts remain upbeat on the stock heading into the print. In a note to clients Friday, Goldman Sachs said investor expectations are low resulting from softer trends industrywide. But analysts said that based on feedback from their distributor and retailer contacts, the Corona and Modelo parent is primed for a beat on the highest and bottom lines. Wall Street expects the corporate to earn $3.46 per share on revenues of $2.67 billion, in accordance with estimates compiled by LSEG. We’ll even be in search of commentary on how the summer is shaping up for its key Mexican beer brands, and whether there are any green shoots in Constellation’s struggling wine-and-spirits business. Up next: The U.S. stock market closes early on Wednesday, at 1 p.m. ET, ahead of the Fourth of July. It’s closed on Thursday in observance of the vacation. Before the break, though, we’ll get a take a look at private payroll growth in June via ADP’s employment survey on Wednesday morning together with weekly initial jobless claims. (See here for a full list of the stocks in Jim Cramer’s Charitable Trust.) As a subscriber to the CNBC Investing Club with Jim Cramer, you’ll 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. If Jim has talked a few stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.

Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street.

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