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☆ Biogen tops estimates, raises profit guidance as Alzheimer's drug Leqembi gains traction
▼ + stars: | 2024-10-30 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

A test tube is seen in front of displayed Biogen logo in this illustration taken on, December 1, 2021. Biogen on Wednesday reported third-quarter revenue and adjusted earnings that topped expectations while raising its full-year profit guidance, as sales of its breakthrough Alzheimer's drug, Leqembi, and other new products gain traction. Leqembi, which Biogen shares with the Japanese drugmaker Eisai, became the second drug proven to slow the progression of Alzheimer's to win approval in the U.S. last summer. The drug posted just $10 million in sales last year following its launch. That compares with a net loss of $68.1 million, or 47 cents per share, for the same period a year ago.

Persons: Biogen, StreetAccount Organizations: U.S, Wall Street, LSEG Locations: U.S

☆ Patients on Alzheimer's drug Leqembi see benefits over three years, Eisai study says
▼ + stars: | 2024-07-30 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The newly FDA approved Alzheimer's treatment Leqembi is prepared at Abington Neurological Associates in Abington, PA., on Tuesday, November 7, 2023. The breakthrough Alzheimer's drug Leqembi slowed disease progression in patients over three years, demonstrating the need for them to stay on the treatment long term, according to new data released Tuesday by Japanese drugmaker Eisai. The study results on Leqembi, which Eisai shares with Biogen , also found that a patient's Alzheimer's disease worsens after they stop treatment. The results are a first glimpse at what Alzheimer's patients' future could look like on therapies such as Leqembi, which is currently taken twice a month through an infusion. By 2050, the number of Alzheimer's patients is projected to rise to almost 13 million in the U.S.

Persons: Lynn Kramer, Leqembi, Eisai, Kramer Organizations: FDA, Abington Neurological Associates, Biogen, CNBC, Alzheimer's Association International Conference, Alzheimer's Association Locations: Abington, Abington , PA, U.S, Philadelphia

☆ European drug regulator rejects Alzheimer's treatment Leqembi from Biogen, Eisai
▼ + stars: | 2024-07-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai , creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. But it almost always follows the drug regulator's recommendations. The European Medicines Agency's human medicines committee recommended against granting marketing authorization for Leqembi. Leqembi and Kisunla are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. In 2021, the European Medicines Agency rejected Aduhelm.

Persons: Eisai, Leqembi, Eli Lilly, Kisunla, Aduhelm Organizations: U.S, European Commission, U.S . Food, Drug Administration, Medicines, European Medicines Agency, Alzheimer's Locations: Biogen, U.S, Japan, South Korea, China, Israel, Europe, Alzheimer's Europe

☆ A successful Alzheimer's drug will help Eli Lilly join the $1 trillion club
▼ + stars: | 2024-06-11 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +7 min

Eli Lilly became the most valuable health-care company in the world on the back of its blockbuster diabetes and obesity drugs. The billions of dollars in Eli Lilly is investing in manufacturing capacity support the idea that the long-term opportunity is immense. Adding Eli Lilly to the market could help address some of the obstacles that limited Leqembi's sales early on. Eli Lilly, which has spent billions in search of a successful Alzheimer's treatment , had hoped for donanemab to be approved by now. A sign with the company logo sits outside of the headquarters campus of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana.

Persons: Eli Lilly, donanemab, Eli Lilly's, Donanemab, Leqembi —, Biogen, —, Jim Cramer's, Ken Langone, Morgan Stanley, Cantor Fitzgerald, Leqembi, Jim Cramer, Jim, Scott Olson Organizations: Food and Drug Administration, FactSet, Novo Nordisk, FDA, GE Healthcare, CNBC, Company, Getty Locations: GLP, Indianapolis , Indiana

Biogen will stop developing its Alzheimer’s treatment Aduhelm, a drug once seen as a potential blockbuster before stumbling soon after its launch a couple years ago. The company also is helping Japanese drugmaker Eisai sell another Alzheimer’s treatment, Leqembi, which already has full FDA approval. Leqembi is the first medicine that’s been convincingly shown to slow the cognitive decline caused by Alzheimer’s disease, though only modestly. Political Cartoons View All 253 ImagesAduhelm was the first new Alzheimer’s disease drug introduced in nearly two decades. But doctors were hesitant to prescribe the intravenous drug, given weak evidence that the drug slows Alzheimer’s.

Persons: drugmaker, Biogen, that’s, Aduhelm Organizations: Food and Drug Administration, Regulators, FDA, Cambridge, Inc Locations: Japanese, Cambridge , Massachusetts

☆ Biogen drops controversial Alzheimer's drug Aduhelm to focus on Leqembi, experimental treatments
▼ + stars: | 2024-01-31 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Biogen on Wednesday said it will discontinue the sale and development of its older and highly controversial Alzheimer's drug Aduhelm to refocus the company's efforts to treat the memory-robbing disease. The biotech company will focus on rolling out Leqembi, a newly approved Alzheimer's drug it developed with Japanese drugmaker Eisai . The U.S. Food and Drug Administration greenlit Aduhelm in 2021 under a program that fast-tracks promising treatments. The company said it will redistribute a large portion of the resources associated with Aduhelm to the rest of its Alzheimer's drug portfolio. Among the other Alzheimer's drugs Biogen has in development is BIIB080, which targets a toxic protein called tau in the brain.

Persons: Biogen, Aduhelm Organizations: U.S . Food, Drug Administration, CNBC PRO Locations: U.S, Swiss

☆ Pfizer's twice-daily weight loss pill joins a long list of obesity drug flops
▼ + stars: | 2023-12-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

That includes Novo Nordisk 's Wegovy and diabetes treatment Ozempic as well as Eli Lilly 's diabetes drug Mounjaro. They have all skyrocketed in popularity — and slipped into shortages — over the last year for safely and successfully causing significant weight loss. But before the current weight loss industry gold rush, the path to treating obesity was strewn with failures dating back decades. In its full-year 2019 earnings, Eisai reported that Lorcaserin had sales of $28.1 million in the U.S. for the year. Sanofi's rimonabantAn obesity drug called rimonabant from Sanofi and Aventis was withdrawn from all markets in 2008 due to the risk of serious psychiatric problems, including suicide.

Persons: Eli Lilly, drugmakers, lorcaserin, Eisai, Lorcaserin Organizations: Getty, Pfizer, Novo Nordisk, U.S, Drug Administration, FDA, Aventis, Abbott Laboratories Locations: U.S, Sanofi

TOKYO (AP) — Japan's health ministry has approved Leqembi, a drug for Alzheimer’s disease that was jointly developed by Japanese and U.S. pharmaceutical companies. It's the first drug for treatment of the disease in a country with a rapidly aging population. Developed by Japanese drugmaker Eisai Co. and U.S. biotechnology firm Biogen Inc., the drug's approval in Japan comes two months after it was endorsed by the U.S. Food and Drug Administration. Eisai said it will conduct a post-marketing special use survey in all patients administered the drug until enough data is collected from unspecified number of patients under Japanese health ministry procedures. Eisai is committed to delivering Leqembi to people who need it and their families “as a new treatment,” said Haruo Naito, the company’s CEO.

Persons: Fumio Kishida, Kishida, Eisai, Leqembi, ”, Haruo Naito Organizations: TOKYO, Biogen Inc, U.S . Food, Drug Administration, Kyodo Locations: Japan

☆ Medicare will pay for Alzheimer's drug Leqembi. What patients and doctors should know
▼ + stars: | 2023-07-08 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on January 20, 2023. Medicare has agreed to pay for the Alzheimer's treatment Leqembi, a major turning point for patients who are diagnosed with the early stages of the disease. Medicare coverage is crucial for most patients to have any hope of being able to afford Leqembi. Eisai has priced Leqembi at $26,500 per year before insurance coverage, which is extraordinarily expensive for Medicare patients, who have a median income of about $30,000. Patients with traditional Medicare will pay 20% of the bill for Leqembi, according to the federal Centers for Medicare and Medicaid Services.

Persons: Leqembi, Biogen, Tricia Neuman, Neuman Organizations: Reuters, Medicare, Food and Drug Administration, Services Locations: Cambridge , Massachusetts

CNN —The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Broad Medicare coverage of Leqembi and similar types of medications to slow the progression of Alzheimer’s disease would probably have a big impact on the program’s spending.

Persons: drugmakers, hasn’t, “, ’ ”, Joe Montminy, Lawrence Honig, “ It’s, ”, Honig, it’s, Leqembi, ” Honig, Georges Naasan, Sue Rottura, ” Drugmaker Eisai, “ You’re, Ivan Cheung, Eisai, ” Montminy, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, Medicare, Services, CMS, Columbia University Irving Medical Center, Alzheimer’s, Behavioral, CNN Health, Kaiser Family Foundation Locations: Mount, Florida

TOKYO, June 13 - Japan's benchmark Nikkei gauge surged on Tuesday, closing over 33,000 for the first time in 33 years, led by technology shares on expectations of a flood of investment in chip-related companies. The Nikkei (.N225) climbed for a third-straight session, adding 1.8% to 33,018.65, closing above the key psychological level for the first time since July 1990. Global shares climbed on Monday ahead of closely watched U.S. inflation data on and policy decisions from the Federal Reserve, Bank of Japan, and other central banks. Toyota's EV strategy "was well received by the market, and also last night the U.S. market was strong, so we have a strong market today," said Daiwa Securities strategist Kenji Abe. The auto sector (.TEWP.T) rose 3.4% to become the best performer among the Tokyo Stock Exchange's 33 industry sub-indexes.

Persons: Kenji Abe, Drugmaker Eisai, Rocky Swift, Sonia Cheema Organizations: Nikkei, SoftBank Group Corp, Intel Corp, Advantest Corp, Toyota Motor Corp, Global, Federal Reserve, Bank of Japan, Daiwa, Tokyo Stock, Thomson Locations: TOKYO, U.S

☆ Biogen isn't concerned about competing with Eli Lilly in the Alzheimer’s drug space, CEO says
▼ + stars: | 2023-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

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.

☆ 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

☆ Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab
▼ + stars: | 2023-03-06 | by ( ) www.reuters.com time to read: 1 min

TOKYO, March 6 (Reuters) - Japanese drugmaker Eisai Co Ltd (4523.T) and its U.S. partner Biogen Inc (BIIB.O) said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer's treatment Lecanemab. The FDA accepted Eisai's supplemental Biologics License Application for the drug, supporting transition from the accelerated approval granted in January, the drugmaker said in a statement. Reporting by Rocky Swift; editing by Diane CraftOur Standards: The Thomson Reuters Trust Principles.

☆ Stocks making the biggest moves midday: Deere, Airbnb, AutoNation, Moderna and more
▼ + stars: | 2023-02-17 | by ( Michelle Fox | ) www.cnbc.com time to read: +3 min

Check out the companies making the biggest moves midday:Deere — Shares rose 7.7% after the company reported earnings-per-share of $6.55 for its fiscal first quarter, topping the $5.57 expected by analysts polled by Refinitiv. Some Wall Street analysts remained cautious on the stock, citing risks including competition and slower-than-expected consumer adoption of alternative accommodations. Still, earnings and revenue missed Wall Street estimates. The sports betting company reported a loss of 53 cents per share on revenue of $855 million. The real estate company reported a 57 cent per share loss on $480 million of revenue.

☆ Maker of promising Alzheimer's drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.

☆ Eli Lilly Alzheimer's drug setback extends rival Biogen's lead - analysts
▼ + stars: | 2023-01-20 | by ( ) www.reuters.com time to read: +2 min

Jan 20 (Reuters) - The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said. "This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023. The setback for Lilly comes just weeks after the FDA granted Biogen Inc (BIIB.O) and Japanese drugmaker Eisai Co Ltd's (4523.T) accelerated approval for their Alzheimer's drug Leqembi. read moreAnalysts are waiting for the traditional approval of Biogen's drug and for wider health insurance coverage before they expect sales of the drug to pick up. "But if there is anything wrong with the (Eli Lilly) data set, it is easier to reject an unapproved drug than remove an approved drug from market," said Skorney.

☆ Here's where to look for the next developments in the fight against Alzheimer's disease
▼ + stars: | 2023-01-17 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +10 min

The Centers for Disease Control and Prevention estimates 5.8 million Americans were living with the disease in 2020 . BIIB 6M mountain Biogen's stock is trading well above its lows Leqembi treats Alzheimer's disease by targeting amyloid-beta plaques in the brain. Attention shifts to Eli Lilly Shares of other Alzheimer's drug developers have often mirrored Biogen's moves. Small drug developers Smaller Alzheimer's drug developers have also been boosted by research developments. Still in an early stage of its research, Prothena has traded as a proxy for developments in Alzheimer's treatment.

☆ Eisai files for full FDA approval for Alzheimer's drug Leqembi
▼ + stars: | 2023-01-07 | by ( ) www.reuters.com time to read: 1 min

Jan 6 (Reuters) - Japanese drugmaker Eisai Co Ltd (4523.T) said on Saturday it had submitted an application to the U.S. Food and Drug Administration for a standard review of its Alzheimer's drug Leqembi, which was recently approved under the agency's accelerated review process. Reporting by Bhanvi Satija in Bengaluru; Editing by William MallardOur Standards: The Thomson Reuters Trust Principles.

☆ New Alzheimer’s drug shows promise in slowing disease but may contain significant risks, study shows
▼ + stars: | 2022-11-30 | by ( The Associated Press | ) www.nbcnews.com time to read: +5 min

An experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening, researchers reported Tuesday — but it remains unclear how much difference that might make in people’s lives. Now the companies are providing full results of the study of nearly 1,800 people in the earliest stages of the mind-robbing disease. Also, lecanemab recipients were 31% less likely to advance to the next stage of the disease during the study. The trial is important because it shows a drug that attacks a sticky protein called amyloid — considered one of several culprits behind Alzheimer’s — can delay disease progression, said Maria Carrillo, chief science officer for the Alzheimer’s Association. Eisai said Tuesday the deaths can’t be attributed to the Alzheimer’s drug.

☆ Eisai shares plunge 10% in Tokyo after report of death in Alzheimer's trial
▼ + stars: | 2022-11-29 | by ( ) www.reuters.com time to read: +1 min

TOKYO, Nov 29 (Reuters) - Shares in Japanese drugmaker Eisai Co (4523.T) headed for their biggest plunge in more than a year on Tuesday after a report that a woman in a trial of the company's Alzheimer's disease treatment died. Eisai's shares sank 10% to 8,595 yen, leading decliners on the benchmark Nikkei index (.N225), which slid 0.5% in the morning session. Shares in Biogen sank 4.3% on Monday. Eisai and Biogen shares have been on a roller coaster in recent years on prospects for their candidates to battle dementia. Lecanemab was shown to slow cognitive and functional decline in a large trial of patients in the early stages of Alzheimer's disease, Eisai and Biogen said in September.

The Japanese drugmaker Eisai said Tuesday its experimental drug for Alzheimer’s disease helped slow cognitive decline in patients in the early stages of the illness. The company said that in a phase 3 clinical trial, the drug, called lecanemab, slowed cognitive decline by 27% after 18 months. The results may offer renewed hope to Alzheimer’s patients after the U.S. drugmaker Biogen’s botched rollout of its drug, Aduhelm, last year. Biogen partnered with Eisai in the commercialization of the new drug, although Eisai led its development and the phase 3 trial. Two similar drugs — from Roche and Eli Lilly — are expected to release late-stage clinical trial results over the next few months.

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