Streetbeat News

ESALF

Eisai Co Ltd

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

CEO

Haruo Naito

Industry

Pharmaceutical Preparation Manufacturing

Open

32.50

Mkt cap

8.5B

Volume

460

High

32.50

P/E Ratio

32.26

52-wk high

52.97

Low

30.00

Div yield

0.04

52-wk low

30.00

The European Medicines Agency (EMA) has postponed the Oral Explanation for Biogen Inc and Eisai Co Ltd's Alzheimer's drug, Lecanemab, due to procedural issues. This delay affects the drug's review process, initially expected to conclude by June 30, 2024. The postponement follows a recent court ruling impacting EMA's policy on managing conflicts of interest among its Scientific Advisory Groups. Despite the delay, an approval is still anticipated in the second half of 2024. BIIB shares dropped 1.10% following the news.

Portfolio Pulse from Vandana Singh

March 22, 2024 | 5:44 pm

Merck & Co Inc (MRK) and Eisai Co Ltd (ESALY, ESALF) announced the Phase 3 LEAP-001 trial of Keytruda plus Lenvima did not meet primary endpoints for treating advanced or recurrent endometrial carcinoma. This follows previous trial failures in lung cancer and melanoma. However, a trial in renal cell carcinoma showed a benefit. MRK shares saw a slight premarket increase.

Portfolio Pulse from Vandana Singh

December 08, 2023 | 1:26 pm

The U.S. Centers for Medicare and Medicaid Services has revised its policy to permit multiple uses of amyloid PET scans, a tool for Alzheimer's diagnosis. This change aligns with the eligibility criteria for new Alzheimer's drugs and benefits patients seeking access to such drugs, including Eisai Co Ltd/Biogen Inc's Leqembi and Eli Lilly And Co's experimental drug, donanemab. The policy change also ensures government reimbursement for drugs like Leqembi by confirming the presence of amyloid in the brain.

Portfolio Pulse from Vandana Singh

October 13, 2023 | 7:10 pm

LuMind CEO Hampus Hillerstrom is advocating for access to Alzheimer's drugs made by Eisai Co Ltd (OTC:ESALY)/ Biogen Inc's (NASDAQ:BIIB) and Eli Lilly And Co's (NYSE:LLY) for people with Down syndrome. Hillerstrom is at odds with neurologists who recommend against immediate use, citing untested safety risks. Advocacy groups are lobbying Eisai and Lilly to conduct safety trials specifically for Down syndrome and for Medicare policy changes to ensure these individuals are not disqualified from treatment reimbursements.

Portfolio Pulse from Vandana Singh

October 10, 2023 | 4:35 pm

Several significant business events have occurred. Ford of Canada has reached a collective agreement with Unifor union, including wage increases and pension improvements. Amazon has invested $4 billion in AI startup Anthropic. PhonePe, backed by Walmart, has launched the Indus AppStore Developer Platform to challenge Google's dominance in India. Goodyear plans to redefine its operational presence in the Asia Pacific region. Pfizer's RSVpreF vaccine has been recommended by the CDC for pregnant people. Mercedes Benz has partnered with Mastercard to introduce in-car digital payments. Novartis plans to spin-off the Sandoz business. Eisai and Biogen's Alzheimer treatment Leqembi has been approved in Japan. Alcoa has appointed William F. Oplinger as President and CEO. TransCode Therapeutics' stock is trading higher after positive results with its therapeutic candidate, TTX-MC138. Tyson Foods and Perdue Farms are under investigation over alleged child labor violations. OpenAI has unveiled a new feature for its ChatGPT application, enabling verbal responses. Apple's iOS 17 update allows users to opt for a search engine other than Google. Austrian Airlines faced backlash for making inaccurate environmental claims.

Portfolio Pulse from Vandana Singh

September 25, 2023 | 2:58 pm

Japan's regulatory authority has approved Leqembi, an Alzheimer's treatment developed by Eisai Co Ltd and Biogen Inc. The approval is based on Phase 3 data from the global Clarity AD clinical trial, which showed statistically significant results and confirmed the clinical benefit of Leqembi. Eisai will conduct a post-marketing survey in all patients administered Leqembi.

Portfolio Pulse from Vandana Singh

September 25, 2023 | 2:41 pm

Merck & Co Inc and Eisai Co Ltd have announced that two Phase 3 trials, LEAP-006 and LEAP-008, evaluating Keytuda plus Lenvima in patients with certain types of metastatic non-small cell lung cancer, did not meet their primary endpoints. The safety profiles of the treatment regimens were consistent with previous studies. Keytruda plus Lenvima is approved in the U.S., the EU, Japan, and other countries for advanced renal cell carcinoma and certain types of advanced endometrial carcinoma.

Portfolio Pulse from Vandana Singh

September 22, 2023 | 2:21 pm

Merck and Eisai's two Phase 3 trials evaluating Keytruda plus Lenvima in certain types of metastatic non-small cell lung cancer did not meet its dual primary endpoints of overall survival and progression-free survival.

Portfolio Pulse from Benzinga Newsdesk

September 22, 2023 | 10:49 am

Merck & Co Inc and Eisai Ltd have announced the discontinuation of the Phase 3 LEAP-010 trial evaluating Keytruda plus Lenvima for recurrent or metastatic head and neck squamous cell carcinoma. The decision was made after the therapy failed to show an improvement in overall survival in the second analysis. This follows the discontinuation of the LEAP-017 and LEAP-003 trials earlier this year and the LEAP-002 trial last year.

Portfolio Pulse from Vandana Singh

August 25, 2023 | 3:58 pm

Eisai and Biogen have presented the latest analysis of Lecanemab's effect on biomarker changes and subcutaneous dosing at AAIC 2023.

Portfolio Pulse from Benzinga Newsdesk

July 20, 2023 | 4:51 am

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