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TYO:4523

11 stories mentioning TYO:4523Updated 5d ago

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Asia

Eisai's LEQEMBI Pen Approved in Japan as New Under-the-Skin Option for Alzheimer's Treatment

Eisai (TYO:4523) and Biogen's LEQEMBI(r) Pen, a new under-the-skin (subcutaneous) version of the Alzheimer's drug lecanemab, has been approved in Japan as a new route of administration.The autoinjector pen allows patients or their care partners to give the injection at home once a week, using two pens totaling 500 mg, instead of receiving intravenous infusions every two weeks at a hospital.This option offers greater convenience and flexibility, potentially reducing the need for clinic visits and easing the burden on patients, care partners, and healthcare resources, according to a Tokyo bourse filing on Wednesday.Japan becomes the third country globally to approve the under-the-skin version of LEQEMBI.

TYO:4523
Asia

Correction: Eisai, Biogen Secure China's Nod for Self-Injection Version of Leqembi

(Corrects the complete product name in the lead and headline, and its planned launch date in the fourth paragraph)China's National Medical Products Administration (NMPA) approved Eisai (TYO:4523) and Biogen's subcutaneous autoinjector version of anti-amyloid beta protofibril antibody Leqembi as an initiation treatment for mild cognitive impairment due to Alzheimer's disease or mild AD dementia.The self-administered autoinjector is given once weekly at 500 mg through two 250 mg injections, according to a joint release on Thursday.The approval adds at-home subcutaneous treatment to the existing every-two-week intravenous regimen, with patients able to switch between the two administration methods during treatment, the release said.The product will be launched during Eisai's fiscal 2026, ending March 31, 2027.Shares of Eisai rose nearly 2% at market close.

TYO:4523
Asia

China's NMPA Approves Eisai's Early Alzheimer's, Dementia Drug

China's National Medical Products Administration (NMPA) approved Eisai's (TYO:4523) anti-amyloid beta protofibril antibody Leqembi, or lecanemab, as an initiation treatment for mild cognitive impairment due to Alzheimer's disease or mild AD dementia.Leqembi SC-AI is a self-administered autoinjector given once weekly at 500 mg through two 250 mg injections, according to a Thursday filing with the Japan bourse.The approval adds at-home subcutaneous treatment to the existing every-two-week intravenous regimen, with patients able to switch between the two administration methods during treatment, the release said.Leqembi was launched in China in June 2024, it said.Shares of Eisai rose nearly 2% at market close.

TYO:4523
Asia

Eisai's Profit Rises 26% in Fiscal Q1

Eisai's (TYO:4523) net profit attributable to owners of the parent jumped 26% to 18.2 billion yen in the fiscal first quarter from 14.5 billion yen a year earlier.The drugmaker's basic earnings per share increased to 64.71 yen from 51.35 yen a year ago, according to a Monday Tokyo Stock Exchange filing.Revenue climbed 16% to 234.3 billion yen in the three months ended June 30 from 202.7 billion yen in the prior-year period.For the fiscal year ending March 31, 2027, the company expects revenue of 883.5 billion yen and basic earnings per share of 185.00 yen.

TYO:4523
Asia

FDA Approves Eisai, Biogen's LEQEMBI Injection for Early Alzheimer's

The US Food and Drug Administration has approved Eisai (TYO:4523) and Nasdaq-listed Biogen's supplemental Biologics License Application for LEQEMBI IQLIK, a once-weekly subcutaneous injection administered via autoinjector for early Alzheimer's disease.The new formulation is an at-home alternative to intravenous infusion from treatment initiation, with a 500 mg weekly dose given as two 15-second injections, according to a Tokyo bourse filing on Monday.The approval allows patients to switch between IV and subcutaneous administration as needed.

$BIOGENTYO:4523
Asia

Eisai to Invest GBP 48 Million in UK Site for Cold-Chain Drug Capabilities

Eisai (TYO:4523) will invest 48 million pounds in its manufacturing site in Hatfield, Hertfordshire, to establish supply chain and packaging capabilities for current and future medicines requiring cold-chain management, according to a Monday statement.The investment is supported by the UK government's Life Sciences Innovative Manufacturing Fund.The project will enable Eisai to transition from using external contract manufacturers to an in-house packaging model for temperature-controlled medicines, including its lecanemab treatment for Alzheimer's disease.The expansion includes the construction of ambient and cold-chain warehouses, enhanced goods receipt and dispatch facilities, and the installation of new packaging lines.Eisai said the investment will strengthen the Hatfield facility's role as a global manufacturing hub serving Europe, the Middle East and Africa, while improving production flexibility and quality management.

TYO:4523
Asia

UK, Japan Enter Into GBP 18 Billion Deal to Boost Clean Energy, Jobs, Next-Generation Tech

British and Japanese leaders are set to finalize an 18 billion pound sterling agreement expected to create "tens of thousands of new jobs" in offshore wind, infrastructure, and finance, according to a statement on Saturday.Under the deal, several Japanese companies committed 5-year investments to UK projects, including 2 billion pounds sterling by Mitsubishi Estate(TYO:3481), 3.8 billion pounds sterling by Mitsui Fudosan (TYO:8801), and 500 million pounds sterling by Nomura Real Estate (TYO:3231).Additional pledges include Mizuho Financial's 3 billion pound sterling expansion of its UK operations, Eisai's (TYO:4523) 48 million pound sterling government-backed facility upgrade, and an offshore wind compact facilitating up to 9 billion pound sterling for floating wind projects in the North and Celtic Seas.Legal & General also broke ground on a 135 million pound sterling London housing project in partnership with Nomura (TYO:8604), marking the firm's first UK homebuilding venture.Prime Minister Keir Starmer will host his Japanese counterpart and business delegates in London before the G7 meeting in France, where over 10 commercial and government agreements are expected to be signed.

Nikkei 225TYO:3231TYO:3481TYO:4523TYO:8604TYO:8801
Asia

Jefferies Adjusts Eisai's Price Target to 4,000 Yen From 5,000 Yen, Keeps at Hold

Eisai (TYO:4523) has an average rating of hold and mean price target of 4,877.86 yen, according to analysts polled by FactSet.

TYO:4523
Asia

Eisai Posts 88 Billion Yen Leqembi Revenue For Fiscal 2025

Eisai (TYO:4523) said global revenue for Alzheimer's treatment Leqembi reached 88 billion yen on a preliminary basis for the year ended March, according to a Thursday filing on the Tokyo Stock Exchange.The U.S. accounted for 44.6 billion yen of sales, followed by Japan at 24.4 billion yen and China at 12.4 billion yen.

TYO:4523
Asia

Eisai, Merck's Phase 3 Kidney Cancer Drug Combo Trial Fails to Meet Survival Endpoints

Japanese pharmaceutical firm Eisai (TYO:4523) and U.S.-based Merck's experimental combination therapies failed to meet the dual primary endpoints of progression-free survival and overall survival in a Phase 3 trial.The trial was evaluating first-line treatment for advanced clear cell renal cell carcinoma, a form of kidney cancer that accounts for approximately 80% of all cases, according to a joint statement on Tuesday.The LITESPARK-012 study tested two regimens: Keytruda plus Lenvima plus Welireg, and MK-1308A (a co-formulation of Keytruda with an investigational antibody) plus Lenvima, against the established combination of Keytruda and Lenvima in 1,688 patients.An interim analysis revealed that neither experimental combination met the study's two primary goals of improving overall survival and progression-free survival compared with the standard treatment.

TYO:4523
Asia

Jefferies Adjusts Eisai's Price Target to 5,000 Yen from 4,600 Yen, Keeps at Hold

Eisai (TYO:4523) has an average rating of hold and mean price target of 5,052.86 yen, according to analysts polled by FactSet.

TYO:4523

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