Streetbeat News

ESAIY

Eisai Co Ltd

https://www.eisai.co.jp/

CEO

Haruo Naito

Industry

Pharmaceutical Preparation Manufacturing

Open

8.30

Mkt cap

8.8B

Volume

21K

High

8.30

P/E Ratio

35.22

52-wk high

13.57

Low

8.05

Div yield

N/A

52-wk low

7.87

Biogen's Alzheimer's drug, Leqembi, has been approved by the UK's Medicines and Healthcare products Regulatory Agency. However, the National Institute for Health and Care Excellence (NICE) does not recommend it for NHS reimbursement due to cost-effectiveness concerns. Despite showing a small benefit in slowing disease progression, the drug's high costs and limited long-term evidence are barriers.

Portfolio Pulse from Vandana Singh

August 22, 2024 | 5:45 pm

The FDA has approved Eli Lilly's Kisunla (donanemab) for early symptomatic Alzheimer's disease, making it the second anti-beta-amyloid monoclonal antibody approved in recent years. Kisunla shows significant efficacy in reducing amyloid plaques and slowing disease progression. Despite its higher cost compared to Biogen's Leqembi, Kisunla offers the potential for lower long-term costs due to the option of stopping treatment early. Analysts see this approval as a positive development for the Alzheimer's treatment market.

Portfolio Pulse from Vandana Singh

July 03, 2024 | 4:13 pm

Eli Lilly's Alzheimer's treatment, donanemab, received a favorable verdict from an FDA advisory committee, boosting its stock potential. BofA analyst Geoff Meacham reiterated a Buy rating with a $1,000 price target for Eli Lilly (LLY). The verdict supports regulatory approval for donanemab, which is expected to have a label similar to Biogen's (BIIB) Leqembi. However, challenges in commercial implementation and potential risks from competing products and drug pricing system restructuring remain.

Portfolio Pulse from Nabaparna Bhattacharya

June 11, 2024 | 6:19 pm

Eisai and Biogen announced that the FDA has accepted Eisai's Supplemental Biologics License Application for LEQEMBI IV maintenance dosing to treat early Alzheimer's disease. The PDUFA action date is set for January 25, 2025.

Portfolio Pulse from Benzinga Newsdesk

June 10, 2024 | 12:10 am

Biogen and Eisai have initiated a rolling Biologics License Application with the US FDA for subcutaneous LEQEMBI to treat early Alzheimer's disease under Fast Track status. LEQEMBI is already approved in the U.S., Japan, and China, with applications submitted in multiple other countries. Eisai also submitted a Supplemental Biologics License Application for monthly intravenous maintenance dosing.

Portfolio Pulse from Benzinga Newsdesk

May 15, 2024 | 6:51 am

Eisai has completed the submission of a supplemental Biologics License Application for LEQEMBI® for IV maintenance dosing in the treatment of early Alzheimer's disease to the U.S. FDA. This marks a significant step in the development and potential market expansion of LEQEMBI®, which could impact the treatment landscape for Alzheimer's disease.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 6:17 am

Biogen (BIIB) and Eisai's (ESAIY) LEQEMBI intravenous infusion has received approval in Japan for the treatment of Alzheimer's disease.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 5:59 am

Merck and Eisai have announced that their Phase 3 LEAP-010 trial evaluating KEYTRUDA plus LENVIMA did not result in an overall survival benefit for patients. The study will be closed due to the low likelihood of reaching the protocol-specified threshold for statistical significance.

Portfolio Pulse from Benzinga Newsdesk

August 25, 2023 | 10:19 am

Stock futures dipped slightly on Friday as traders awaited the June non-farm payrolls report. Thursday's trading saw stocks close lower due to data suggesting a tight labor market and speculation of a rate hike at the upcoming Federal Reserve meeting. The SPDR S&P 500 ETF Trust (NYSE:SPY) and the Invesco QQQ ETF (NASDAQ:QQQ) both fell in premarket trading. Levi Strauss & Co. (NYSE:LEVI), Biogen, Inc. (NYSE:BIIB), and Costco Wholesale Corp. (NASDAQ:COST) are in focus due to recent developments.

Portfolio Pulse from Shanthi Rexaline

July 07, 2023 | 10:52 am

The U.S. Food and Drug Administration (FDA) has converted the approval status of Leqembi, a novel Alzheimer's disease treatment, from accelerated to traditional approval. This follows a confirmatory trial that verified the drug's clinical benefit. Leqembi, developed by Eisai Inc., is the first amyloid beta-directed antibody to receive such conversion. The drug reduces amyloid plaques in the brain, a key feature of Alzheimer's disease. The approval was initially granted under the Accelerated Approval pathway, which required a confirmatory study post-approval.

Portfolio Pulse from Happy Mohamed

July 06, 2023 | 8:48 pm

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